Not Found
No
The device description and performance studies focus on the material properties and clinical efficacy of a collagen wound dressing, with no mention of AI or ML.
Yes
The device is intended for the local management of wounds and control of minor bleeding, which are therapeutic actions.
No
The device is a wound dressing intended for the control of bleeding and management of exuding wounds. It does not perform any diagnostic function.
No
The device description explicitly states that BIOPAD® is a "sponge shaped device, constituted exclusively by lyophilized type 1 native heterologous collagen extracted from horse flexor tendon," which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that BIOPAD® is a wound dressing for the control of minor bleeding and the local management of various types of wounds. This is a topical application for treating a physical condition.
- Device Description: The description reinforces that it's a wound dressing for topical use and describes its physical form and composition (collagen sponge).
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. Its function is purely therapeutic and protective for the wound itself.
IVD devices are used to perform tests in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. BIOPAD® is applied in vivo (on the body) to treat a wound.
N/A
Intended Use / Indications for Use
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,
- Donor sites and other bleeding surfaces,
- Dehisced surgical incisions,
- Draining wounds,
- Lacerations,
- Podiatric, and
- Post-laser surgery.
The product is supplied sterile and for one-time-use only.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals in a clinical setting (implied by "sale by or on the order of a physician").
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)
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.
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.
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
N/A
0
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,"
1
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.
2
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
3
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 /
4
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 LifeScience |
| Corporation | ||
| Fibracol Plus collagen wound dressing with | ||
| alginate | K982597 | Johnson & Johnson Medical |
| SIS Wound Dressing II | K993490 | Cook Biotech Inc. |
5
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.
6
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.