Stimulen™ Collagen is a sterile primary single use dressing comprised of soluble modified bovine collagen base. The Stimulen™ collagen is soluble in the wound fluid and supplied as a powder or gel or sheet.

AI/ML Overview

The provided text describes a 510(k) summary for the Stimulen™ Collagen wound dressing, which establishes substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, or a study showing the device meets acceptance criteria in the format requested.

Here's why and what information is missing:

Acceptance Criteria & Reported Performance: The document lists "Indications For Use" and compares the Stimulen™ Collagen to predicate devices based on characteristics like material, collagen source, biodegradability, biocompatibility, and sterility. However, it does not provide specific quantitative acceptance criteria (e.g., "device must achieve 90% wound closure by 4 weeks") or reported performance metrics against such criteria. The "Safety" section mentions biocompatibility tests (Primary Skin Irritation Test, Acute Systemic Injection Test, Intracutaneous Test) demonstrated Stimulen collagen to be "non-toxic and non-irritating," but these are general safety findings, not performance metrics against acceptance criteria for efficacy.
Study Details: There is no description of a study designed to prove the device meets acceptance criteria. The 510(k) process for this device relies on demonstrating "substantial equivalence" to legally marketed predicate devices, not on presenting novel clinical study data for efficacy against predefined acceptance criteria.

Therefore, I cannot populate the requested table or provide the detailed study information regarding sample size, data provenance, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

The closest I can come to fulfilling your request, based solely on the provided text, is to list the claims made about the device and its characteristics as compared to predicate devices, but these are not "acceptance criteria" for a clinical performance study.

Summary of what cannot be provided from the text:

Table of Acceptance Criteria and Reported Device Performance: Not present. The document focuses on demonstrating equivalence in design, function, material, and intended use, not clinical performance metrics.
Sample size used for the test set and the data provenance: No performance study data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study is detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document is a 510(k) summary focused on regulatory clearance through substantial equivalence, which typically does not involve the detailed clinical efficacy studies and performance criteria evaluation you are asking about for a novel device.

Summary

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Image /page/0/Picture/23 description: The image shows the logo for Southwest Technologies Inc. The logo consists of a circular emblem with a stylized "S" containing a flask inside. To the right of the emblem is the company name, "southwest technologies inc." in a sans-serif font, followed by the tagline "treating the world well" in a smaller font.

AUG - 9 2004

Ko30774
(letterhead)
510(k) Summary

STIMULEN™ COLLAGEN

Safety and effectiveness information submitted in accordance with 21CFR § 807

Submitter/ Contact Person:

Edward I. Stout, President Southwest Technologies, Inc. 1746 Levee Road N. Kansas City, MO. 64116

Telephone:	(816) 221-2442
Fax:	(816) 221-3995
email:	swtech@birch.net

July 1, 2004 Date prepared:

Device Name and Classification

Stimulen™ Collagen Proprietary Name: Wound Dressing Common Name: Classification Name: Classification:

Manufacturer

Southwest Technologies, Inc. 1746 Levee Road N. Kansas City, MO. 64116

Substantial Equivalence Claim

Medifil™ by BioCore (K 910944) hyCure™ by Hymed Group (K955506) Collatek™ by BioCore (K012990) HeliDerm™ by Integra (K990086)

Device Description

Elasto-Gel/™

Toe
Aid™

t® Finger Bobs™ Crutch-Mate™

E-1

M
Gold Dust
TM

ﻢ

North Kansas City, Missouri 64116 1746 Levee Road phone: 816-221-2442 800-247-9951 fax: 816-221-3995 e-mail: swtech@birch.net website: elastogel.com

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Intended Use

Stimulen™ Collagen is indicated for the management of wounds including full and partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, partial thickness thickness wounds, pressure uters (stages I-V), vehous stable and and other sites and other surface wounds.

Comparison to Predicate Devices

Device Name	Stimulen™	Medifil™	HyCure™	Collatek™	HeliDerm™
Manufacturer	Southwest Tech.	BioCore	Hymed Group	BioCore	Integra
IndicationsFor use	Prolonged use inThe management ofFull and partial thick-Ness wounds.	Used to manageFull and partialThickness woundswith minimal toHeavy exudate.	Used in theManagementof chronic andAcute wounds.	Used to managefull and partialThickness woundsWith moderate toHeavy exudate.	Used in theManagement ofModerately toHeavily exudatingWounds and theControl of minorBleeding.
Material	Soluble modifiedCollagen	Type I Collagen	96% derived fromType I Collagen	Type I Collagen	Type I Collagen
CollagenSource	Bovine	Bovine	BovineFlexor Tendon	Bovine	BovineFlexor Tendon
Biodegradable	Yes	Yes	Yes	Yes	Yes
Bio-Compatibility	Yes	Yes	Yes	Yes	Yes
Sterile	Yes	Yes	Yes	Yes	Yes

Technological characteristics:

Stimulen™ Modified Collagen is a dry particulate powder. which will dissolve I. in warm wound exudate
Stimulen is also supplied as an amorphous gel. II.
Stimulen is also supplied as a gel sheet. III.

Safety

Chemical analysis indicated the amino acid composition are essentially equivalent to the HyCure collagen. Elemental metal analysis also shows the similar levels of trace metals.

Bioburden analysis of the non-sterile Stimulen showed low levels of contamination, less than 100 c.f.u. Biocompatibility tests, Primary Skin Irritation Test, Acute Systemic Injection Test, Intracutaneous Test demonstrated the Stimulen collagen to be non-toxic and non-irritating.

Sterility and Packaging

Stimulen™ Modified Collagen will be packaged in a suitable container(vial, bottle, pouch). The container and contents will be sterilized at an SAL of 10 " in accordance with AAMI/ISO 11137.

Conclusion

Stimulen™ Modified Collagen is essentially equivalent in design, function, source of substrate materials, and indicated use, to the commercially available predicate devices, and therefore meets the requirements as defined in 21 CFR § 807.

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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized emblem featuring three curved lines that resemble a bird in flight or a flowing design. The emblem is black, and the text is also in a dark color, contrasting with the likely white or light background of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Dr. Edward I. Stout President Southwest Technologies, Inc. 1746 Levee Road N. Kansas City, Missouri 64116

Re: K030774

Trade/Device Name: Stimulen™ Collagen Regulatory Class: Unclassified Product Code: KGN Dated: July 1, 2004 Received: July 6, 2004

Dear Dr. Stout:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have decembled the arrested predicate devices marketed in interstate for use stated in the enclosure) to regally manced provide Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the character with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provinces of the Act . The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The
You may, therefore, market the device, subject to the general posicstion, listi You may, therefore, market the device, subject to the most registration, listing of
general controls provisions of the Act include requirements for annual registrations ond general controls provisions of the receive requirementalibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entisting and to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Feactar Regarines
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 Please be advised that FDA s issuation of a succession in ther requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decemmanon that your and your Federal agencies. You must of any Federal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, montag, contracturing practice requirements as set a CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. Edward I. Stout

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin manteang your antial equivalence of your device to a legally premarket notification. The FDA midning of backandal vip.
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 If you desire specific advice for your as 101) 594-4659. Also, please note the regulation entitled, comact the Office of Comphalled as (Se notification" (21CFR Part 807.97). You may obtain Misblailing by reference to premientonibilities under the Act from the Division of Small other general information of your respective at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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Indications for Use

510(k) Number (if known): _K030774 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Stimulen™ Collagen is indicated for prolonged use (24 hr to 30 days) in the management of wounds including:

·full and partial thickness wounds
·pressure ulcers (stages I-IV)
•venous stasis ulcers
·diabetic ulcers
·partial thickness burns
·acute wounds
·abrasions
•traumatic wounds healing by secondary intention
•donor sites and other surface wounds

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

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)

Miriam C. Provost

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number_KO30774_________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A