The Augustine Medical Wound Care System is intended to be used for the local management of wounds by maintaining moisture and body temperature in the wound bed and is indicated for partial and full thickness wounds, such as, Stage I through IV venous, arterial, diabetic, and pressure ulcers.

Device Description

The wound care system is comprised of a power supply/battery charger, heater control unit, heater card, and a sterile dressing/bandage called a Wound Cover which supports the heater card and holds it away from the wound and skin.

The Wound Cover is a disposable, single-use, sterile, non wound-contact dressing. The Wound Cover may be used either as a stand-alone wound dressing or as part of the Augustine Medical Wound Care System. The Wound Cover incorporates a clear or opaque window. The clear window allows the caregiver to view and assess the tissue. The Wound Cover surrounds and protects the wound, absorbs wound exudate and allows active warming of the periwound area by the application of radiant heat.

The warming components of the system include a thin heater card, a control unit, and a power supply/battery charger. The system operates on standard wall outlet electricity or the self-contained batteries. The heater card is sized appropriately to the Wound Cover and attaches easily over the clear window of the Wound Cover. The heater card does not contact the wound and is intended for single patient use. The control unit incorporates temperature safety limits.

AI/ML Overview

Below is an analysis of the provided text regarding the Augustine Medical Wound Care System, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance is based on the device being "substantially equivalent" to predicate devices, rather than meeting specific numerical performance criteria in the way a diagnostic device might. The core acceptance criteria revolve around safety and effectiveness comparable to existing devices for the same intended use.

Acceptance Criterion (Implicit from SE Determination)	Reported Device Performance
Similar Intended Use: Local management of wounds by maintaining moisture and body temperature in the wound bed for partial and full thickness wounds (Stage I-IV venous, arterial, diabetic, and pressure ulcers).	The device's "Intended Use" statement explicitly matches this criterion. Clinical data indicated wound healing with the device was "at least as well as 'standard of care'" for these ulcer types. (pages 14, 16)
No New Questions of Safety or Effectiveness (including heating of periwound area): The additional feature of heating the periwound area should not introduce new safety or effectiveness concerns.	The FDA reviewer determined that heating the periwound area "does not raise new questions of safety and effectiveness because the device only raises the temperature of the wound bed above 'normal' body temperature" and a predicate device (Lyofoam) also claimed to "maintain wound temperature to optimize wound healing." Safety limits for heater cards and prescription-only use by healthcare professionals were also noted. (page 16)
Biocompatibility: Materials used in construction should be biocompatible.	"Biocompatibility testing was performed on the materials used in the construction of the sterile dressing. All materials passed biocompatibility testing and are suitable for this application." (page 20)
Physical Testing: Dimensional inspection, functional performance, electrical safety, electromagnetic compatibility, pressure switch activation, overtemperature safety shut-off, and performance under clinical conditions.	"All testing of the product yielded acceptable results." (page 20)
Similar Materials, Sizes, Configurations, Packaging, and Sterilization	"The Augustine Wound Care System components are constructed of the same or substantially equivalent materials as the predicate products. The sizes and configurations available along with the packaging and sterilization methods are also equivalent." (page 21)
Healing Rates: Wound healing should not be slower with the device compared to standard care.	Clinical data showed "Healing rates were not slower when this device was applied." For Diabetic Ulcers, median percentage reduction in wound area per day was 1.86% for standard care vs. 2.30% for the device. For Venous Stasis Ulcers, values were 3.11% vs. 3.36%. For Pressure Ulcers, values were 1.40% vs. 2.38% (in one study). For Chronic Leg Ulcers, values were 4.85% for the device (no direct comparison value given for standard care in text, but generally implied to be comparable or better). (page 15)

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions several clinical studies were conducted:

Number of Studies: Seven studies (completed or in progress) involving different wound types. (page 15)
Sample Size for Test Set: Specific sample sizes for each study are not provided. The text only gives median percentage reduction values.
Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the studies were likely conducted within the United States, given the context of FDA submission by a US-based company. The data is retrospective in the sense that results were submitted after the studies were, at least partially, completed to address FDA's request for additional information. It's not a prospective, pre-planned IDE study, but rather data gathered from existing or ongoing clinical work.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number or qualifications of experts who established the "ground truth" for the clinical studies. The data presented are wound healing rates (median percentage reduction in wound area per day), which would typically be measured objectively (e.g., planimetry, digital imaging) rather than relying on expert consensus for each individual wound. The "ground truth" here is the measured healing rate itself. The "experts" would be the investigators running the studies.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the data collected in the clinical studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This device, the Augustine Medical Wound Care System, is a wound care treatment system (physical device with heating capability and wound cover) and not an AI/Software as a Medical Device (SaMD) that typically undergoes MRMC studies involving human readers and AI assistance for interpretation. Therefore, no such study was performed or is relevant in this context.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Again, this is a physical medical device, not an algorithm or AI. Standalone performance as typically described for AI/SaMD devices is not applicable. The device's performance is inherently linked to its physical application and interaction with the wound and human users (healthcare professionals).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

The ground truth for evaluating the device's effectiveness appears to be primarily outcomes data, specifically:

Wound Healing Rates: "median percentage reduction of the wound area per day" (page 15).
Absence of Adverse Effects: "no reports of any adverse effects or extended healing times" (page 15).
Biocompatibility Test Results: "All materials passed biocompatibility testing" (page 20).
Physical Test Results: "All testing of the product yielded acceptable results" (page 20).

8. The Sample Size for the Training Set

The concept of a "training set" is fundamentally tied to machine learning algorithms. Since the Augustine Medical Wound Care System is a physical medical device, there is no "training set" in the context of an AI algorithm. Its development would have involved engineering design, material selection, and iterative physical testing/prototyping, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no algorithm or "training set" for this physical device. The "ground truth" for its development would be engineering specifications, material properties, and the intended physiological effects, established through standard biomedical engineering and clinical research practices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 27, 2022

Augustine Medical, Inc. Scott D. Augustine, M.D. Chief Executive Officer 10393 West 70th Street Eden Prairie, Minnesota 55344

Re: K963293

Trade/Device Name: Augustine Medical Wound Care System Model 68XXX Regulation Number: 21 CFR 878.4020 Regulation Name: Occlusive Wound Dressing Regulatory Class: Class I Product Code: MSA

Dear Scott D. Augustine, M.D.:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 28, 1997. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 878.4020.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito(@fda.hhs.gov.

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features an abstract image of an eagle with its wings spread, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 1997

Scott D. Augustine, MD CEO Augustine Medical, Inc. 10393 West 70th Street Eden Prairie, Minnesota 55344

K963293 Re: Augustine Medical Wound Care System, Model 68XXX Regulatory Class: Unclassified Product Code: MSA Dated: February 14, 1997 Received: February 18, 1997

Dear Dr. Augustine:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been redious books of the provisions of the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, rood, bray, and in the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

This device may not be labeled for use on third degree 1. burns.
This device may not be labeled as having any accelerating 2. effect on the rate of wound healing or epithelization.
This device may not be labeled as a long-term, 3. permanent, or no-change dressing, or as an artificial (synthetic) skin.
This device may not be labeled as a treatment or a cure 4 . for any type of wound.

{2}------------------------------------------------

Page 2 - Dr. Scott D. Augustine

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through a periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note

$\checkmark$

{3}------------------------------------------------

Page 3 - Dr. Scott D. Augustine

the regulation entitled, "Misbranding by reference to
r the regulation entitled, "Misblanding mi
premarket notification" (21 CFR 807.97). Other general premarket notification" (2) Crk over the Act may be
information on your responsibilities under thrers Assista information on your responsibilities under corers Assistance
obtained from the Division of Small Manufacturers Assistance obtained from the Division of Silai or 301-443-6597 or at
at its toll-free number (800) 638-2041 or 301-443-6597 or at at its toll-free number (800) 636-2007 01 302 100.
its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) number: K963293

Device name: Augustine Medical (Trade Name) Wound Care System

Model 68XXX ..... ........................

Indications for use:

The Augustine Medical Wound Care System is intended to be used for the local management I he Augustine Medical Would Care By ton to internature in the wound bed and is indicated of wounds by manitaming mostere are 8005 to appen IV venous, arterial, diabetic, and pressure ulcers.

PLEASE DO NOT WRITE BELOW THIS LINE— CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (QDE)

Prescription Use
(Per 21 CFR 801-109)
or
(Division Sign-Off)
Division of General Restorative Devices K963293
510(k) Number the Counter Use

Augustine Medical, Inc.

{5}------------------------------------------------

510(K) ROUTE SLIP

DXXK

510 (k) NUMBER K963293 PANEL SU DIVISION DGRD BRANCH PRSB TRADE NAME AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX COMMON NAME AUGUSTINE MEDICAL WOUND CARE SYSTEM PRODUCT CODE MGP DRESSING, WOUND AND BURN, OCCLUSIVE

APPLICANT	AUGUSTINE MEDICAL, INC.
SHORT NAME	AUGUMEDI
CONTACT	SCOTT D AUGUSTINE
DIVISION
ADDRESS	10393 WEST 70TH ST.
	EDEN PRAIRIE, MN 55344
PHONE NO.	(612) 947-1200
FAX NO.	(612) 947-1400
MANUFACTURER	AUGUSTINE MEDICAL, INC.
	STERIGENICS INTL., INC.
	STERIGENICS INTL., INC.
	ISOMEDIX OPERATIONS, INC.
REGISTRATION NO.	2183725
	1420032
	1058584
	1450662

DATE ON SUBMISSION 19-AUG-96 DATE RECEIVED IN ODE 21-AUG-96 DECISION _____________________________________________________________________________________________________________________________________________________________________

DATE DUE TO 510(K) STAFF 04-NOV-96

DECISION DATE

DATE DECISION DUE 19-NOV-96

SUPPLEMENTS	SUBMITTED	RECEIVED	DUE POS	DUE	OUT
S001S002	21-NOV-9614-FEB-97	22-NOV-9618-FEB-97	05-FEB-9704-MAY-97	20-FEB-9719-MAY-97	31-JAN-97
CORRESPONDENCE	SENT	DUE BACK
C001C002	05-NOV-9631-JAN-97	05-DEC-9602-MAR-97	HOLD LETTERHOLD LETTER
OTHERSUBMISSIONS	SUBMITTED	RECEIVED	DUE POS	DUE	OUT
ADD-TO-FILE	02-OCT-96	02-OCT-96	01-DEC-96
Is this 510(k) identified as a Class III device				YES	/ NO

{6}------------------------------------------------

Scott D. Augustine, MD CEO Augustine Medical, Inc. 10393 West 70th Street Eden Prairie, Minnesota 55344

K963293 Re: R965293 Regulatory Class: Unclassified Product Code: MSA Dated: February 14, 1997 Received: February 18, 1997

Dear Dr. Augustine:

We have reviewed your Section 510(k) notification of intent to we have reviewed your boosed above and we have determined the market the market the active really equivalent (for the indications for device is substancearly organism to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Commerce price Amendments or to devices that have been Medical Device imending with the provisions of the Federal reclassified in accoration may and (the Act). You may, therefore, rood, brug, und cobmodel to the general controls provisions
market your device subject to the general controls and the market your device basys
of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

This device may not be labeled for use on third degree 1. burns .
This device may not be labeled as having any accelerating 2. fills device may
This device may not be labeled as a long-term, 3. fill device may -------------------------------------------------------------------------------------------------------------------------------------------------------------(synthetic) skin.
This device may not be labeled as a treatment or a cure 4 . for any type of wound.

{7}------------------------------------------------

Page 2 - Dr. Scott D. Augustine

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please cromoti the Office of Compliance at (301) 594-4639. Also, please note

{8}------------------------------------------------

Page 3 - Dr. Scott D. Augustine

the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

OFFICE	SURNAME	DATE
HF2-410	Knaul	3/23/97
Z-410	S. Rhodes	3/27/97
Z410	Dell	3/6/97

{9}------------------------------------------------

bcc:	HFZ-401	DMC
	HFZ-403	RChissler
	HFZ-410	DGRD
	D.O.

d/t:

. ... .. ... ... ............................................................................................................................................................

☆/セ:HFZ-410 : DXK : BJT : 3 / 25 / 97

{10}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES	Public Health Service
	Food And Drug Administration
	Memorandum

	March 21, 1997
From:	Reviewer(s) - Name(s) David Krause
Subject:	510(k) Number: K963293/52
To:	The Record - It is my recommendation that the subject 510(k) Notification:

Refused to accept.
Requires additional information (other than refuse to accept).
Accepted for review
Is substantially equivalent to marketed devices.
NOT substantially equivalent to marketed devices.
Other (e.g., exempt by regulation, not a device, duplicate, etc.)

use K-27 SN letter for wound Dressings

Is this device subject to Postmarket Surveillance?	YES NO
Is this device subject to the Tracking Regulation?	YES NO
Was clinical data necessary to support the review of this 510(k)?	YES NO
Is this a prescription device?	YES NO
Was this 510(k) reviewed by a Third Party?	YES NO

This 510(k) contains:
Truthful and Accurate Statement Requested Enclosed
(required for originals received 3-14-95 and after)
A 510(k) summary OR A 510(k) statement
The required certification and summary for class III devices
The indication-for use form (required for originals received 1-1-96 and after)

The submitter requests under 21 CFR 807.95 (doesn't apply for SEs):

No Confidentiality Confidentiality for 90 day's Continued Confidentiality exceeding 90 days
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Predicate Product Code with panel and class:	Additional Product Code(s) with panel (optional):
79 MSA-Dressing, Wound & Burn, (Unclassified) Heated Occlusive	79 MGP Occlusive wound + burn Dressing
Review: Styst Rhode (Branch Chief)	PRSA (Branch Code) 3/27/97 (Date)
Final Review: (Division Director)	3/27/97 (Date)

Revised: 11-20-95

:

{11}------------------------------------------------

Image /page/11/Figure/0 description: This image is a flowchart outlining the 510(k) "Substantial Equivalence" decision-making process. The flowchart begins with descriptive information about a new or marketed device and proceeds through a series of questions and decision points. These points assess descriptive characteristics, performance data, and equivalence, ultimately leading to a determination of substantial equivalence.

510(%) submissions compare row downed devices. FDA requests reditional balorouskon if thprelationship helmoch urarketed and "precieste" (pre-Amendments or reclassified poss-Am adments) desice is undesar.
This decision is normally based on description alone, but limited testing informating somedial seconding sequired
··· · Data may be in the 510(k), other S10(k)s, the Contects classification likes, or the licerature,

{12}------------------------------------------------

REVISED: 3/14/95

"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION

K963293

David Krause, Biologist_______________________________________________________________________________________________________________________________________________________ Reviewer: ____

DGRD / PRSB Division/Branch:______________________________________________________________________________________________________________________________________________________________

Device Name: _ Augustine Medical Wound Care System, Model 68XXX

ClearSite Wound Dressing Product To Which Compared [510 (K) Number If Known] : Product To Which Compared [510 (K) Number If Known : CreatsTee Mound Dressen
(K914207 & K920677), Lyofoam Wound Dressing (K860085) and Seabrook Micro Temp
(K914207 (K843146) Pump and Pads (K843146) .

		YES	NO
1.	Is Product A Device	X		If NO = Stop
2.	Is Device Subject To 510(k)?	X		If NO = Stop
3.	Same Indication Statement?	X		If YES = Go To 5
4.	Do Differences Alter The Effect OrRaise New Issues of Safety OrEffectiveness?	NA		If YES = Stop NE
5.	Same Technological Characteristics?		X	If YES = Go To 7
6.	Could The New Characteristics AffectSafety Or Effectiveness?	X		If YES = Go To 8
7.	Descriptive Characteristics PreciseEnough?	NA		If NO = Go To 10If YES = Stop SE
8.	New Types Of Safety Or EffectivenessQuestions?		X	If YES = Stop NE
9.	Accepted Scientific Methods Exist?	X		If NO = Stop NE
10.	Performance Data Available?	X		If NO = Request Data
11.	Data Demonstrate Equivalence?	X		Final Decision:SE

The subject device is intended to be used for the local Intended bse: The subject device is intended body temperature in the
management of wounds by maintaining moisture and body temperature in the Fr managment of wounds by maintaining mostcure and body company such as
wound bear and is indicated for partial and full thickness would wound bed and is indicated for partial and rail one one one of the stage I through IV venous, arterial, diabel Cover and Heater Control Unit, the W begin on intinution with the Wound Cover and area. The Wound
Heater Card is designed to provide heat to the perimound area. The Wound cover is intended to provide a gas permeable barrier which will absorb
Cover is intended to provide a gas permeable barrier which will absorb
ent is in the closintain a warm Cover is intended to provide a gas permeable barres. Miller in the maintain
Device Description: This wound care device (no trade name has been Device Description: This wound care creatment system comprised of an adhesive
assigned yell at heater (warming insert), and a heater controller. The 2. assigned yet) is a woud care treatment system compress and a beater controller.
bandage, radiant heater (warming insert) , and a heater controller. system is designed to irradiate a cutaneous ulceration or other wound
system is designed to raise the periwoud temperature. The Augustin system is designed to Irradiate a cacinound temperature.
with infrared energy to raise the perivound temperature. The Augustine with infrared energy to raise the perised of : a heater concrol unit (two Medical Wound Care System is comprised of : a neater concerners at
heater control units are available for the appLication of temperatures at heater control units are arailable for the approcession a wound Cover 18°C and ports the heater card and protects the wound (the wound cover is
which supply the heater card and protects the wound (the wound) ; which supports the heater card and procedes the womin (che wound) ;
designed would a clear or opague window which is elevated from the wound) ; will a first a clear or opaque window wilch is elevated from the works.
and a power supply/battery charger. The top of the bandage has a pocket

{13}------------------------------------------------

that accepts the warming insert. The warming insert is comected to the states
t the warming businessia a 48.0 inch long detachable inco that accepts the warming insert. The warming theer is combined on the many of the char accorporaller via a 48.0 inch long decamment.
heater controller via a portable, hand held device.

EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED

Explain why not a device: The Augustine Medical Wound Care System is a
nd to belovice 1. medical device.
medical device.
Exprazintly indication differ from the predicate device's
How does the indications are generally the same. How does the new indication dirrer from to be re-3 .

2 .

7 .

indication: "The shalled is not a new effect or safety or effectiveness
"State while 4 . N/A. issue:
lesuribe the new technological characteristics: This device has the Masterial Describe the new technological chause in the wound site. 5.
Capania and characteristics could or could not affect safety of Explain how new characteristics could or could not arreed barby of the ର . the wound.
che would.
Explain how descriptive characteristics are not precise enough:
Characteriptive characteristics are not precise enough: N/A.
Explain new types of safety or effectiveness questions raised or why the Explain new types of safety or effectiveness questions from the may be
guestions are not heal 8. will the wound heal.
Will why existing scientific methods can not be used: Existing
Explain who excel 9 . methods can be used.
methods can be abournance data is needed: Clinical work which compares
Chinian for and when this device is used and when standard of care Explain what performance data is needed: "Cliffedrials of courselves of care
healing of wounds when this device is used and when standard of care
s and wounds weed 10. treatments are used.
Explain how the performance data demonstrates that the device is or is Explain how the performance data demonstrates were not slower when this
not substantially equivalent: Healing rates were not slower when this
substantially equivalent: Heal 11. device was applied.

ATTACH ADDITIONAL SUPPORTING INFORMATION HERE

{14}------------------------------------------------

MEMO TO THE RECORD 510(K) REVIEW K963293/S2

DATE: March 26, 1997 FROM: Dr. David Krause, Biologist/Reviewer

OFFICE: HFZ-410 DIVISION: DGRD/PRSB

DEVICE NAME: Augustine Medical Wound Care System, Model 68XXX DEVICE NAME: Augustine Medical Wound Care System Medical, Inc., 10393 West 70th Street,

COMPANY NAME and ADDRESS: Augustic Medical, Inc., 10393 West 70th Street, Eden Prairie, MN 55344

Background: Augustine Medical, Inc. submitted the original 510(k) for this device on Background: Augustine Medical, Inc. scoler 5, 1996, FDA asked () additional information
August 19, 1996. In a letter dated November 5, 1996, FDA, asked November 21 August 19, 1996. In a letter dated November 1998, i binal 510(k), dated November 21,
in the form of 7 deficiencies. In a supplement to the original 510(kg), dated in the form of 7 deficiences. Thi a supplime to the issues. All of the questions were 1996, Augustine Medical responded to mest cated January 31, 1997, FDA responded to adequately addressed except for one. In a lection Medical to respond to the form of statement: Additional Information is required. This information needs to be in the form of statement: Additional Information is required. This is an environment in which healing data which evaluate whether or not the covec essendard wound care therapies arailable to
can take place in the same amount of time as the standard the energer places on bis can take place in the same anount of thin as the twound that the sponsor places on his patients. Data should be supplied for each type of would and in the Medical's reply to that statement.

Intended Use: The subject device is intended to be used for the local management of Intended Use: The subject device is included to be wound bed and is indicated for wounds by mainlaining mostude and body teampe the venous, arterial, diabetic, and partial and full thickness woulds, such as stage I the Wound Cover and Heater Control Unit, a pressure uicers. Whien used in conformation the periwound area. The Wound Cover is the Heater Card is designed to provide meat which will absorb wound exadate and maintain a intended to provide a gas permication barres while ClearSite Wound Dressing and the warm and most periwound environment. "Donost identical intended uses, except for the Lyotoan Wound Dressing predicates mate announded use of localized heat heating of the perivound area. The seablook device has in and the device is not for open wounds.

Device Description: This wound care device (no trade name has been assigned yet) is a Device Description: This wound care dovice (inc sive bandage, radiant heater (warming wound care treatment system comprison of an designed to irradiate a cutaneous ulceration of insert), and a neater controller. The System is designed to mature .
other wound with infrared energy to raise the periwound temperature. The Augustine Medical

{15}------------------------------------------------

Wound Care System is comprised of: a heater control unit (two heater control units are
s a many and the many and associated and 42%); a heater card; a Wound Care System is computed on: a news at 38℃ and 42℃); a heater card; a
available for the application of temperatures the heater card and protec available for the application of temperatures and and protects the wound
sterile/bandage called a Wound Cover which supports the hevated from the sterile/bandage called a Wound Cover winch opporte window which is elevated from the (the wound cover is designed with a cical of opeque of the bandage has a pocket that wound); and a power supply/battly cinalg. " is copyreded to the heater controller via a
accepts the warming insert. The warming insert is considered to be a portable, hand accepts the warming insert. The warming mset is comicered to be a portable, hand held device.

Review of Supplement K963293/S002: The deficiency to which Augustine Medical is Review of Supplement K96529353002: " Including response will be summarized in bold
responding is included in italics, Augustine Medical's response will be summarized in bold responding is meluded in names, Frage, Fragge in normal type.

Additional Information is required. This information needs to be in the form of data Additional Information is required. This Information mentin which healing
which evaluate whether or not the device establishes an environment in which healing which evaluale wherer of not the active standard wound care therapies. can take place in the same anount of time us the should the sponsor
available to patients. Data should be supplied for each type of wound that the sponsor places on his "Indications for Use" form.

The sponsor states that, to date, there are seven studies completed or in progress The sponsor states that, to date, there are seven station Medical Wound Care
involving different wound types being treated with the Augustin of are adverse offects of involving different wound types being treated what no reports of any adverse effects or
System. During all of these studies there have Modical Word Care System. For System. During times when using the Augustine Medical Wound Care System. For extended healing times with using the Augustion of the wound area per day was 1.86%
Diabetic Ulcers, the median percentage reduction Modical Wound Care Diabetic Ulcers, the median percentage reduction of vgustine Medical Wound Care
for standard of care treatment and 2.30% for the and 2.30% respectively for standard of care treathent and 2.30% the were 3.11% and 3.36%, respectively, for Device. For Venous Siasis Olcers, these value and 2.38% in a second study, while it was Pressure the Values Were 1.40 % in one sales and finally for Chronic Leg Une 4.85% for the Augustine Device, and Imally 101 Chrome - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Wound Care Device.

The sponsor includes a table which shows the data for these studies. The sponsor also The sponsor includes a lable winen silows are used the Augustine Medical includes letters Iron 4 nivestigations who are letters indicate that the Augustine Medical Wound Care System in studies. An of these fotors and may, indeed, augment healing to some degree. This is an adequate response.

Substantial Equivalence Rationale: When this 510(k) originally came to FDA, on August Substantial Equivalence Ranonate. "Hether or not this device would fit the product 19, 1996, there were questions as to when of the device was heated also raised the description of a would and built dressing. The found "Not Substantially Equivalent" because of possibility that the device would note to on on a so needed to know whether

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or not the device actually allowed wounds to heal or did it, in fact, inhibit the healing process.
As of not the device actually anowed would to mult of their of telephone and letter requests for additional information.

The Intended Use of the device is equivalent to a wound and burn dressing. As stated on the The Intended Ose of the device is equiration Medical Wound Care System is intended to be "Indications for Use "Form." The Fragueding moisture and body temperature in used for the local management of wounds of fifthickness wounds, such as, stage I through IV venous, arterial, diabetic, and pressure ulcers." Both the elearSite and Lyofoam Wound I v vehous, arterial, diabete, and prossare and specify pressure ulcers (stages Dressings include wound management in the the stopes of ulcers) for the Augustine I to I y as muchous. "The adde supported by clinical data which indicate that the wound Medical Wound Care Bystein are supported of take place at least as well as "standard of care" for these types of ulcers.

The question of heating the periwound area does not raise new questions of safety and The question of neating the percenture aises the temperature of the wound bed above "normal effectiveliess because the devel for rurther, the sponsors of the Lyofoam wound dressing included the following claim in their 510(k): "maintains wound temperature to optimize mound healing." The device contains two heater cards, one at 39°C and one at 42°C. The 42°C heater card is not indicated for leg wounds where compromised circulation may be 42 C heater can 15 not marsing against using the 42°C heater card for these leg woulds. Also, the device is prescription and comes with adequate instructions for use which will assure that the device is only applied by a health care professional.

This device and the additional information which was sent to FDA in response to telephone and letter requests is reviewed in detail in previous memos.

Product Code Update: I received a new product code for this device from Bill Huff on I Tounct Cour Putter w product code is 79 MSA, Dressing, Wound and Burn, Occlusive, Heated. Please see memos dated March 17 and March 18 for details.

Based on my review of the information included in the original 510(k) Recommendation: submission and the subsequent supplements, I recommend that the subject device, The Augustine Medical Wound Care System, is substantially equivalent to the listed legally marketed predicates (see original review).

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Classification:

79 MSA, Dressing, Wound and Burn, Occlusive, Heated (Unclassified)

David Krause 3/26/97
David Krause, Ph.D. (Date)

Biologist/Reviewer, Division of General and Restorative Devices Plastic and Reconstructive Surgery Branch

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Indications for Use

510(k) number (if known):

Device name: The Augustine Medical (Trade Name) Wound Care System

Indications for use:

The Augustine Medical Wound Care System is intended to be used for wound care.

PLEASE DO NOT WRITE BELOW THIS LINE-- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801-109)

Over the Counter Use

i v

Augustine Medical, Inc.

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K963293

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

510(k) Summary

Augustine Medical Wound Care System

MAR 2 8 1997

General Information

Classification	Unclassified
Trade Name	Augustine Medical Wound Care System
Submitter	Augustine Medical, Inc.10993 West 70th StreetEden Prairie, MN 55344(612) 947-1200
Contact	Scott D. Augustine, MDCEO

Predicate Devices

The Augustine Medical Wound Care System is substantially equivalent in safety and effectiveness in its intended use to these predicate devices:

ClearSite Wound Dressing K914207 & K920677 Manufactured by NDM Corporation, 3040 E. River Road, Dayton, Ohio 45439-1436, (800) 783-1767

Lyofoam Wound Dressing K860085 Manufactured by Acme United Corporation, Medical Division, 75 Kings Highway Cutoff, Fairfield, CT 06430-5340, (800) 243-9852

Seabrook MicroTemp Pump and Pads K843146 Manufactured by Seabrook, Inc. 4043 McMann Road, Cincinnati, OH 45245, (800) 477-7757

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Device Description

Intended Use

The Wound Care System is intended to be used for the local management of wounds by maintaining moisture and body temperature in the wound bed and is indicated for partial and full thickness wounds, such as, Stage I through IV venous, arterial, diabetic, and pressure ulcers.

Testing

Biocompatibility testing was performed on the materials used in the construction of the sterile dressing. All materials passed biocompatibility testing and are suitable for this application.

Physical testing of the product included: dimensional inspection, functional performance, electrical safety, electromagnetic compatibility, pressure switch activation, overtemperature safety shut-off, and performance under clinical conditions. All testing of the product yielded acceptable results.

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Summary of Substantial Equivalence

The Augustine Wound Care System components are constructed of the same or substantially equivalent materials as the predicate products. The sizes and configurations available along with the packaging and sterilization methods are also equivalent.

The clinical indications for use are substantially equivalent to the predicate devices as well.

Therefore, because of the similarity of materials to other wound treatment products, the test results, and the similar indications for use of the predicate devices, Augustine Medical believes these products do not raise any new safety or effectiveness issues.

Regulation Number and Section

§ 878.4020 Occlusive wound dressing.

(a)
Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.