K Number

Device Name

GENADYNE A4 WOUND VACUUM SYSTEM

Manufacturer

GENADYNE BIOTECHNOLOGIES, INC.

Date Cleared

2008-12-18

(94 days)

Product Code

OMP BTA

Regulation Number

878.4780

Intended Use

The Genadyne A4 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

Device Description

The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K061367

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard wound vacuum system and does not mention any AI or ML capabilities.

Therapeutic

Yes
The device is indicated for use in patients who would benefit from negative pressure wound therapy, specifically to promote wound healing, which is a therapeutic function.

Diagnostic

No
The device description states it is a "portable suction device that may promote wound healing by the removal of excess exudates, infectious material and tissue debris," and there are no indications that it analyzes or processes data to provide diagnostic information.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "portable suction device," which is a hardware component. The summary also mentions "accessory wound sealing kits," further indicating hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the Genadyne A4 Wound Vacuum System is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states the device is a "portable suction device" used for "negative pressure wound therapy" to "promote wound healing by the removal of excess exudates, infectious material and tissue debris." This is a therapeutic device that acts directly on the wound, not a diagnostic test performed on a sample.
Lack of IVD Characteristics: The provided information does not mention any analysis of biological samples, diagnostic testing, or the detection of specific biomarkers or conditions within a sample.

Therefore, the Genadyne A4 Wound Vacuum System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

BTA, OMP

Device Description

The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing has been completed to demonstrate the safe and effective use of the Genadyne A4 Wound Vacuum System for the intended use.
Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use.
The device kit has been tested and is substantially equivalent to the kit of the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K061367

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.

Summary

K082676 page 1/8

510k Summary

General Information

1. Applicant:
  Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 (t) 516.487.8787 (f) 516.487.7878 www.genadyne.com

DEC 1 8 2008

Mr. Chien-Ming GOH (Andrew) 2. Contact Person: Vice President Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 Tel: 516-487-8787 Fax: 516-487-7878 Andrew@gcnadyne.com

3. Trade/Proprietary Name Including Model Number of Device:

Genadyne A4 Wound Vacuum System

4. Common Name or Classification Name (21 CFR Part 807.87) of Device:

Powered Suction Pump (21 CFR 878.4780, Product Code BTA)

5. Class in which Device has been placed:

Class II

6. Reason for Premarket Notification:

Introduction of a new device that is substantially equivalent to a legally marketed device.

7. Identification of Legally Marketed Device Which We Claim Substantial Equivalence (Predicate Device):

BlueSky VISTA"M Wound Vacuum System, K061367 (Aug 10, 2006)

K082676 Page 2/8

8. Compliance with Requirements of the Federal FD&C Act:

The General and Rostorative Device Panel (DGRD) has classified this device as Class II, 21 CFR 878.4780

Product Code: BTA

9. Kit Certification and Information:

This device kit has been tested and is substantially equivalent to the kit of the predicate device.

Please refer to Attachment E for the performance testing on the dressing kit for both the Genadyne A4 Wound Vacuum System and the predicate device. Please do refer to Attachment F for the kit information and material data safety sheets for each component of the dressing kit.

10. Description of the Device

The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.

11. Intended use of the Device

12. Substantial Equivalence

In establishing substantial equivalence to the predicate device, Genadyne Biotechnologies evaluated the indications for use, material, technology, product snecifications, and energy requirements of the system. Performance testing has been completed to demonstrate the safe and cffective use of the Genadyne A4 Wound Vacuum System for the intended use.

13. Summary of Safety and Effectiveness

Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use.

K082676 Page 3/5

14. Comparison to Predicate Device

Table of Comparison to Legally Marketed Device:

Comparative Information
	New Device	Predicate Device
Company	Genadyne Biotechnologies	BlueSky Medical Group, Inc.
		BlueSky VISTATM Wound Vacuum
System
Device Name	A4 Wound Vacuum System	System
510 (K) Number	K082676	K061367

Technical Data
Suction Capacity	5 liters per minute	8 liters per minute
Max Vacuum	230 mmHg	200 mmHg
Power Requirements	24 VDC, 1A	100-240 V AC, 60 Hz
Battery Type	Ni-MH	Ni-MH
Dimensions and
Weight	200 x 180 x 80 mm / 1.36 Kg	260 x 250 x 106 mm / 1.9 Kg

Accessories
Canisters	800 ml disposable canister with
a build-in hydrophobic shut off
filter for overflow protection	250 ml or 800 ml disposable
canister
Reusable	Yes	Yes

Sterile	Non Sterile	Non Sterile

Accessory Kit
	A4 Wound Sealing Kit which is
based on the teachings of Dr.
Mark Chariker and Dr.
Katherine Jeter1, which includes:	BlueSky Medical Wound Sealing
Kits, which includes:
	- Non-adherent gauze	- Non-adherent gauze
	- Anti-Microbial gauze	- Anti-Microbial gauze
	- Transparent film dressing	- Transparent film dressing
	- Silicone flat drain	- Silicone flat drain
Indications for Use
	The Genadyne A4 Wound
Vacuum System is indicated
for use in patients who
would benefit from negative
pressure wound therapy
particularly as the device
may promote wound healing
by the removal of excess
exudates, infectious material
and tissue debris.	The BlueSky VISTATM Wound
Vacuum System is indicated for
patients who would benefit from a
suction device particularly as the
device may promote wound healing.
Contraindications
	The Genadyne A4 is
contraindicated in the presence
of :	The VISTATM is contraindicated in
the presence of:
	Necrotic tissue	Necrotic tissue
-	Untreated osteomyelitis	Untreated osteomyelitis
-	Malignancy (with exception to
enhance quality of life)	Malignancy (with exception to
enhance quality of life)
	Untreated malnutrition	Untreated malnutrition
	Exposed arteries, veins, or
organs	Exposed arteries, veins, or organs
Precautions
	Precautions should be taken for	Precautions should be taken for
	patients who are or may be:	patients who are or may be:
	Receiving anticoagulant
therapy	Receiving anticoagulant therapy
	Suffering from difficult
hemostasis	Suffering from difficult hemostasis
	Untreated for malnutrition	Untreated for malnutrition
	Non-complaint or combative	Non-complaint or combative
Compliance
	UL 60601-1	UL 60601-1
	CAN/CSA C22.2 No. 601-1-
M90	IEC 0601-1-2
		CAN/CSA C22.2 No. 601.1
Storage / Transport
	-18°C to +43°C (0°F to 110°F)	-30 to +50° C (-22 to 122° F)
	Relative Humidity 10% to 95 %	5 to 90% Humidity, non condensing

	pressure	pressure
Operation	18°C to 34°C (65°F to 94°F)	+5 to +35° C (41 to 95° F)
	Relative Humidity 10% to 95 %	20 to 80 % Humidity, non condensing
	700 - 1060 mbar Atmospheric
pressure	700 - 1060 mbar Atmospheric
pressure
Testing
	IEC 60601-1-2	-
	FCC part 15 Class B	-
	EN 55011	-
	IEC 61000-4-2	-
	IEC 61000-4-3	-

1 Chariker ME, Jeter KF, Tintle TE. Effective management of incisional and cutaneous fistulae with closed suction wound drainage. Contemporary Surg. 1989;(34):59-63.

K082676 page 4/8

K082676 Page 5/6

15. Comparative Performance Evaluation:

The FDA Decision Tree for substantial equivalence was followed and the steps involved have been considered. The rationale for each step is discussed below. For reviewer convenience, the numbering system used by FDA on the decision tree has been followed by Gcnadyne in their process for the substantial equivalence determination rationale.

K082676 page
6/45

510(k) “SUBSTANTIAL EQUIVALENCE”

DECISION-MAKING PROCESS New Device is Compared to Marketed Device * 2 l Descriptive Information Does New Device Have Same NO Do the Differences Alter the Intended Not Substantially about New or Marketed Indication Statement? Therapeutic/Diagnostic/etc. Effect YES Equivalent Determination Device Requested as Needed (in Deciding, May Consider Impact on AES Safety and Effectiveness)? New Device Has Same Intended NO Use and May be "Substantially Equivalent" O New Device Has New Intended {Jse ﺮ ﻟﻠ 4 Does New Device Have Same ර Technological Characteristics, NO Could the New Do the New Characteristics e.g. Design, Materials, etc. ? Characteristics YES Affect Safety or · Raise New Types of Safety YES Effectiveness? or Effectiveness Questions? 5 NO Are the Descriptive NO Characteristics Precise Enough NO to Ensure Equivalence? -8 7 NO Are Performance Data Do Accepted Scientific Available to Assess Equivalence? YES Methods Exist for NO Assessing Effects of the New Characteristics? YES YES ହୁ Performance Are Performance Data Available NO Data Required To Assess Effects of New Characteristics? * YES 9 0 Performance Data Demonstrate Performance Data Demonstrate Equivalence? Equivalence? YES YES NO NO "Substantially Equivalent" へ To べ Determination To

510(k) Submissions compare new devices to marketed devices. FDA requests additional information if the relationship between marketed and "predicate" (pre-Amendments or reclassified post-Amendments) devices is unclear.

本本 This decision is normally based on descriptive information alone, but limited testing information is sometimes required.

*** Data maybe in the 510(k), other 510(k)s, the Center's classification files, or the literature

K0552676 Page 7/8

16. Discussion of Substantial Equivalence:

Note 1: Does new device have same indication statement as the predicate device(s)?

Yes. The Genadyne A4 Wound Vacuum System and the BlueSky VISTATM Wound Vacuum System are both indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

Note 3: Does the device have the same technological characteristics, e.g., design, materials, etc. ?

Yes. The Genadyne A4 Wound Vacuum System is design with a suction pump, can be externally and internally powered and has a collection canister, same as the BlueSky VISTA™ Wound Vacuum System, which also features a suction pump, a collection canister and can be powered externally and internally.

Note 5: Are the descriptive characteristics precise enough to ensure equivalence?

Yes. The characteristics of the Genadyne A4 Wound Vacuum System and the BlueSky VISTATM Wound Vacuum System are precise enough to ensure equivalence, based on the table in item 14 in the 510K Summary.

17. Discussion of Similarities and Differences

Device Similarities

Indication for use

The indication for use is identical for the Genadyne A4 Wound Vacuum System and the predicate device.

Configuration

All devices are sold non-sterile and are intended to be reusable. Devices are compatible with off-the-shelf accessories, such as disposable 800ml canisters.

Basic Product Function

The Genadyne A4 Wound Vacuum System and the predicate device have the same product function of generating a vacuum to provide general use suction and collection of liquids into an off-the-shelf canister reservoir which may promote wound healing for patient who would benefit from it.

K082676 Pages/s

Device Differences

In comparison to the predicate devices, the Genadyne A4 Powered Wound Vacuum System has several differences which do not affect the device safety and effectiveness of the Genadyne A4 Wound Vacuum System. These differences between the Genadyne A4 Wound Vacuum System and the predicate device are described in further detail below.

BlueSky VISTA134 Wound Vacuum System

The differences between the Genadyne A4 Wound Vacuum System and the BlueSky VISTA™ Wound Vacuum System are that the Genadyne A4 Wound Vacuum System is lighter in weight and has a longer battery life. In all other aspects, the Genadyne A4 Wound Vacuum System and the predicate device is substantially equivalent.

18. Conclusions:

Genadyne believes the Genadyne A4 Wound Vacuum System is substantially equivalent to the predicate device.

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular emblem containing the words "DEPARTMENT OF HEALTH + HUMAN SERVICES USA" arranged around the perimeter.

Public Health Service

APR - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genadyne Biotechnologies, Inc. % Mr. Chien-Ming Goh 65 Watermill Lane Great Neck, New York 11021

Re: K082676

Trade/Device Name: Genadyne A4 Wound Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: November 12, 2008 Received: November 14, 2008

Dear Mr. Goh:

This letter corrects our substantially equivalent letter of December 18, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not

limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

K 062676

Indications for Use

510(k) Number (if known):

Device Name: Genadyne A4 Wound Vacuum System

Indications For Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082676

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