BIOPAD® is a collagen wound dressing intended for the control of minor bleeding, and for the local management of moderately to heavy exuding wounds including:

pressure ulcers,
venous stasis ulcers,
diabetic ulcers,
partial and full thickness wounds,
surgical and traumatic wounds,
surgicul and other bleeding surface wounds
dehisced surgical incisions
draining wounds
lacerations
podiatric
post-laser surgery

The product is supplied sterile and for one-time-use only.

Device Description

BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure.

BIOPAD® is a sponge shaped device, constituted exclusively by lyophilized type 1 native heterologous collagen extracted from horse flexor tendon.

When applied to a wound, BIOPAD® constitutes a barrier for wound against exogenous infective agents.

BIOPAD® is the ideal first-aid means to control minor bleeding.

The device may be used by healthcare professionals.

BIOPAD® is supplied sterile and for one-time use only.

AI/ML Overview

This document is a 510(k) Premarket Notification Summary for the BIOPAD® collagen wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a modern AI/software as a medical device (SaMD) submission would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. This submission predates the common expectation for comprehensive performance studies for software-based devices.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Safety:
Biocompatibility: Non-cytotoxic, non-irritant, non-sensitizing.	BIOPAD® was confirmed to be non-cytotoxic, non-irritant, and non-sensitizing according to UNI EN ISO 10993 Part 10. Acute skin irritation and 28-day repeated skin irritation studies (UNI EN ISO 10993 Parts 5 and 10) demonstrated non-irritancy. A reverse mutation study (Ames Test) (UNI EN ISO 10993 Part 3) confirmed it to be non-mutagenic.
Non-pyrogenic: Absence of pyrogens.	Bacterial endotoxins tests (LAL) according to USP 27 confirmed BIOPAD® to be non-pyrogenic.
Sterility: Sufficiently sterile (e.g., SAL better than 10^-6).	BIOPAD® is supplied sterile and gamma-ray irradiated at a validated dose level, assuring a SAL better than 10^-6.
No reported serious adverse effects.	"No side or adverse effects have ever been reported" (though this is based on post-market surveillance/historical data rather than a specific study).
Effectiveness:
Ability to control minor bleeding.	BIOPAD® "demonstrated its efficacy in clinical applications to control minor bleeding."
Ability to manage wounds (e.g., pressure ulcers, diabetic ulcers, surgical wounds, etc.).	BIOPAD® "demonstrated its efficacy... in the management of wounds." The device is intended for local management of moderately to heavy exuding wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, surgical and traumatic wounds, bleeding surface wounds, dehisced surgical incisions, draining wounds, lacerations, podiatric wounds, and post-laser surgery wounds. When applied, it constitutes a barrier against exogenous infective agents. The 510(k) submission relies on substantial equivalence to predicate devices (HeliDerm, Fibracol Plus, SIS Wound Dressing II) that are already marketed for similar indications.
Maintain material, function, intended use, and performance equivalence to predicates.	The submission states BIOPAD® is "substantially equivalent in material, function, intended use and performance to the following commercially available wound dressings..." (listed predicate devices). This is the primary "acceptance criterion" for a 510(k) submission.

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

Sample Size: Not explicitly stated for specific clinical efficacy studies. The biocompatibility and sterility tests would have used specific sample sizes as per their respective standards, but these details are not provided here.
Data Provenance: The biocompatibility, mutagenicity, and pyrogenicity tests are laboratory-based. The claim of clinical efficacy for bleeding control and wound management is stated as "demonstrated its efficacy in clinical applications," suggesting some form of clinical observation or studies, but no specifics on study design, sample size, or country of origin are given. For a 510(k), such clinical data is often not required if substantial equivalence can be shown through technological comparison and non-clinical testing.

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

Not applicable. This device is a wound dressing, not a diagnostic AI/SaMD that requires expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This is a wound dressing, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical wound dressing, not a software algorithm.

7. The Type of Ground Truth Used

Biocompatibility/Safety: Measured directly through laboratory assays (e.g., cytotoxicity assays, irritation tests on animal models, bacterial endotoxin tests).
Efficacy: Stated as "clinical applications" for minor bleeding and wound management. For a 510(k), "ground truth" for efficacy is often established by demonstrating substantial equivalence to legally marketed predicate devices with known efficacy through similar intended use, technological characteristics, and performance data. Specific objective clinical outcome data (e.g., wound healing rates, time to hemostasis) with direct "ground truth" establishment are not detailed here.

8. The Sample Size for the Training Set

Not applicable. This is a physical wound dressing, not a machine learning model.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 11, 2023

Euroresearch S.R.L. c/o E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K040283 Trade/Device Name: BIOPAD® Regulatory Class: Unclassified Product Code: QSY

Dear E. J. Smith:

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 July 22, 2005. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.

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.

Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is the Assistant Director at DHT4B: Division of Infection Control and Plastic Surgery Devices. She also works at OHT4: Office of Surgical and Infection Control Devices. Her office is the Office of Product Evaluation and Quality, and she works at the Center for Devices and Radiological Health. The letter is signed, "Sincerely,"

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2005

Euroresearch S.R.L. c/o Mr. E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K040283

Trade/Device Name: BIOPAD Regulatory Class: Unclassified Product Code: FRO Dated: April 22, 2005 Received: April 25, 2005

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to narket the device in indication we nave reviewed your Section 910(x) premainer is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and ment date of the Medical Device Amendments, or to commerce prior to May 26, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been receasined in assessmed of a premarket approval application (PMA). and Cosment Act (1107 market the device, subject to the general controls provisions of the Act. The You may, therefore, market the device, boojes to courements for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controller "Entroling this " - " " " " be found in the Oous neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issuance or our device complies with other requirements of the Act
that FDA has made a determination that your device complies with other requi that IDA has made a decemmation and Journer Federal agencies. You must or any reactal statutes and regalations and admited to: registration and listing (21 comply with an the Act 3 requirements, mostang, and manufacturing practice requirements as set and CFK Part 807), labeling (21 CFR Part 820); good if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. E. J. Smith

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manisting of substantial equivalence of your device to a legally premaired notheadon: "The Prix misms of casion 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 acrite 101-500-1001 176-0115. Also, please note the regulation entitled, Connact the Office of Company of Company (21CFR Part 807.97). You may obtain Misblanding of Yelerence to premains on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Eu An

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

. ..

Enclosure

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KO40283

Indications for Use

510(k) Number (if known): K040283

Device Name: BIOPAD

Indications for Use:

BIOPAD® is a collagen wound dressing intended for the control of BIOPAD® IS a Collagen Wound "at soomy": "And for the local management of moderately to heavy exuding wounds including:

pressure ulcers,
venous stasis ulcers,
diabetic ulcers,
partial and full thickness wounds,
surgical and traumatic wounds,
surgicul and other bleeding surface wounds
dehisced surgical incisions
draining wounds
lacerations
podiatric
post-laser surgery

The product is supplied sterile and for one-time-use only.

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 OF NEEDED)

Concurrence of CDBH, Office of Device Evaluation (ODE)

Eus G. th

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

Page / of /

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K040283

EURORESEARCHE

JUL 2 2 2005

BIOPAD®

Traditional 510(k) Premarket Notification-SUMMARY

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary for BIOPAD® is being submitted in accordance with the requirements of 21 CFR Part 807.92(c)

DATE OF SUMMARY [807.92(a)(1)] November 13, 2004

SUBMITTER NAME/ADDRESS [807.92(a)(1)]

EURORESEARCH s.r.l. Via Larga, 2 20122 MILAN - Italy

Ph. : 01139 02 8055660 Fx. : 01139 02 72011722

CONTACT PERSON [807.92(a)(1)] Ms Paola Milanesi QA/Regulatory Affairs Director

Ph .: 01139 02 72021293 (direct) Fx.: 01139 02 72011722 e-mail .: paola.milanesi@euroresearch.it

DEVICE INFORMATION [807.92(a)(2)]

Proprietary name Other proprietary names and laboratory codes

Trade name Common name

Classification name

Regulatory Class

BIOPAD®

Gelfix, Condress, Proteita, Stimtes, TN 921, BG PRG, EU 10102: all these brand names identify the same collagen pad undergoing the same manufacturing process, manufactured in the same facility and with the same identical composition and dosage. BIOPAD® Collagen pad, or patch, or sheet, or sponge Wound dressing Unclassified

SUBSTANTIAL EQUIVALENCE [807.92(a)(3)]

BIOPAD® is substantially equivalent in material, function, intended use and performance to the following commercially available wound dressings, that obtained marketing approvals under SE 510(k) Premarket Notification process, and are currently marketed in U.S. for the management of bleedings and wounds, i.e. :

PREDICATE DEVICE	510(K)	MANUFACTURER
HeliDerm collagen wound dressing	K990086	Integra LifeScienceCorporation
Fibracol Plus collagen wound dressing withalginate	K982597	Johnson & Johnson Medical
SIS Wound Dressing II	K993490	Cook Biotech Inc.

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EURORESEARCHE

KO 40 2.83

BIOPAD® Traditional 510(k) Premarket Notification-SUMMARY

DEVICE DESCRIPTION [807.92(a)(4)]

BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure.

BIOPAD® is a sponge shaped device, constituted exclusively by lyophilized type 1 native heterologous collagen extracted from horse flexor tendon.

When applied to a wound, BIOPAD® constitutes a barrier for wound against exogenous infective agents.

BIOPAD® is the ideal first-aid means to control minor bleeding.

The device may be used by healthcare professionals.

BIOPAD® is supplied sterile and for one-time use only.

INDICATIONS FOR USE

BIOPAD® is a collagen wound dressing intended for control of minor bleeding, and for the local management of moderately to heavy exuding wounds including:

Pressure sores, .
t Donor sites and other bleeding surfaces,
Dehisced surgical incisions, �
Draining wounds, .
. Lacerations,
Venous stasis ulcers, �
Diabetic ulcers, ●
Partial and full thickness wounds, .
Post-laser surgery, .
. Podiatric, and
Surgical and traumatic wound. .

The product is supplied sterile and for one-time use.

Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.

Precautions

It is important to apply correctly BIOPAD® previously cleansing the wound', eventually removing the purulent material or necrotic tissues.

BIOPAD® is not intended to replace ligation in case of heavy bleeding.

Side Effects

No side or adverse effects have ever been reported.

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EURORESEARCHE

3/3

BIOPAD® Traditional 510(k) Premarket Notification-SUMMARY

Contraindications

Do not use in patients with known family history of auto-immune diseases, history of ana hylactoid reactions or known hypersensitivity to collagen, both topical and injectable, or in subjects undergoing desensitization therapy to meat products.

TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]

BIOPAD® is designed to protect the wounded area, absorbing wound exudates and controlling minor bleedings, thus representing an effective and safe mean for the management of wounds.

STERILITY

BIOPAD® is available in single sterile package.

It is gamma rays irradiated at a validated dose level that proved to be non-denaturing for the collagen protein, assuring a SAL level better than 1 on 10°.

SAFETY AND EFFECTIVENESS

a) ANIMAL AND LABORATORY TESTINGS [807.92(b)(1)]

A biocompatibility assessment according to UNI EN ISO 10993 Part 10 confirmed BIOPAD® to be non-cytotoxic, non-irritant and non sensitizing.

An acute skin irritation and a 28 days repeated skin irritation study, performed to UNI EN ISO 10993 Parts 5 and 10 demonstrated BIOPAD® to be non-irritant even at repeated applications.

A reverse mutation study (Ames Test) performed according to UNI EN ISO 10993 Part 3 confirmed BIOPAD® to be non-mutagenic.

The bacterial endotoxins tests (LAL) performed according to USP 27 confirmed BIOPAD® to be non pyrogenic.

b) CLINICAL TRIALS AND EXPERIENCE [807.92(b)(2)]

BIOPAD® demonstrated its efficacy in clinical applications to control minor bleeding and in the management of wounds.

CONCLUSIONS [807.92(b)(3)]

Biocompatibility studies have demonstrated BIOPAD® to be non-toxic, non irritating, nonsensitizing, non-cytotoxic and non pyrogenic.

The manufacturing and sterilization processes, performed under QA and GMP, as well as the scientific evidence of the several studies made on the provide a reasonable assurance that BIOPAD® is safe and effective for the proposed use and that, with respect to materials, function, intended use and performance it is substantially equivalent to the predicate devices listed above and to the requirements for 510 (k) Premarket Notification as per 21 CFR Part 807.

Regulation Number and Section

N/A