(286 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interactions of a collagen matrix, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of oral wounds and sores, which implies a therapeutic purpose (treatment, prevention, or mitigation of disease).
No
The device is a wound dressing designed for the management of oral wounds and sores, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product made from collagen matrices in tape, sponge, and plug forms, intended for direct application to wounds. It does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Collagen Dental Wound Dressings are applied directly to the wound in the oral cavity. They are a physical dressing intended to protect and aid in the healing of the wound.
- Intended Use: The intended use clearly states management of oral wounds and sores, which is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and application of the dressing, not on analyzing biological samples.
- Performance Studies: The performance studies described are related to the physical properties, biocompatibility, and resorption of the dressing, not to the accuracy of a diagnostic test.
The device is a therapeutic medical device, specifically a wound dressing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Collagen Dental Wound Dressings are indicated for the management of oral wounds and sores, including:
- Denture sores ●
- Oral ulcers (non-infected or viral) ●
- Periodontal surgical wounds ●
- Suture sites ●
- Burns ●
- Extraction sites
- Surgical wounds ●
- Traumatic wounds ●
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from purified collagen derived from bovine dermis tissue. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings can be removed, replaced or left in situ. If left in situ the dressings will be essentially resorbed in 30 days. Collagen Dental Wound Dressings are available in tape, sponge and plug form, and are supplied sterile, non-pyrogenic and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral wounds and sores
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)
The substantial equivalence of Collagen Dental Wound Dressings and its predicates was demonstrated based on in vitro characterization studies, biocompatibility studies and an animal resorption study.
Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines.
In vitro product characterization testing included evaluation of physical, chemical, and biological properties, with results indicating similarity to the predicate device in terms of composition, dimensions, thickness, density, weight, absorbency, pH, and hydrothermal transition temperature. The device was found to be non-pyrogenic and residues were within acceptable limits.
A series of in vitro and in vivo biocompatibility testing was performed:
- Cytotoxicity (Agarose Overlay, ISO 10993-5; ISO Elution Method, ISO 10993-5): Non-cytotoxic.
- Sensitization (Guinea Pig Maximization, ISO 10993-10): No evidence of causing delayed dermal contact sensitization in the guinea pig.
- Intracutaneous Reactivity (Intracutaneous Study in Rabbits, ISO 10993-10): No erythema or edema from the extract injected intracutaneously into rabbits.
- Pyrogenicity (USP (151) Rabbit Pyrogen Study): The test article was judged as non-pyrogenic.
An in vivo resorption study utilizing a rat subcutaneous model was conducted to evaluate the device as compared to its predicate device with regards to device resorption.
A viral inactivation study was performed to ensure the viral safety of the product.
The results of the non-clinical tests conducted demonstrate that the device is substantially equivalent to the legally marketed 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.
K122115 Collagen Dental Wound Dressing, K142712 Dental Collagen Wound Dressing
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2016
Collagen Matrix, Inc. Ms. Gloria Zuclich Senior Manager of Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436
Re: K152600
Trade/Device Name: Collagen Dental Wound Dressings Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: KGN Dated: May 24, 2016 Received: May 26, 2016
Dear Ms. Zuclich:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): _ K152600
Device Name: Collagen Dental Wound Dressings
Indications for Use:
Collagen Dental Wound Dressings are indicated for the management of oral wounds and sores, including:
- Denture sores ●
- Oral ulcers (non-infected or viral) ●
- Periodontal surgical wounds ●
- Suture sites ●
- Burns ●
- Extraction sites
- Surgical wounds ●
- Traumatic 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)
Page 1 of 1
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510(k) SUMMARY
1. Applicant Information
| Applicant Name: | Collagen Matrix, Inc. |
|---|---|
| Address: | 15 Thornton Road |
| Oakland, New Jersey 07436 USA | |
| Telephone: | (201) 405-1477 Ext. 317 |
| Fax: | (201) 405-1355 |
| Contact Person: | Gloria Zuclich |
| Director of Regulatory Affairs | |
| Date Prepared: | June 2. 2016 |
2. Name of the Device
| Device Trade Name: | Collagen Dental Wound Dressings |
|---|---|
| Device Common Name: | Dental Wound Dressings |
| Device Classification Name: | Dressing, Wound, Collagen |
| Product Code KGN | |
| Unclassified |
| 3. Legally Marketed Devices to Which Substantial Equivalence is Claimed | ||
|---|---|---|
| Primary Predicate: | K122115 Collagen Dental Wound Dressing | |
| Collagen Matrix, Inc. | ||
| Reference Predicate: | K142712 Dental Collagen Wound Dressing | |
| (NovaTape and NovaPlug) |
NovaBone Products, LLC
4. Description of the Device
Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from purified collagen derived from bovine dermis tissue. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings can be removed, replaced or left in situ. If left in situ the dressings will be essentially resorbed in 30 days. Collagen Dental Wound Dressings are available in tape, sponge and plug form, and are supplied sterile, non-pyrogenic and for single use only.
5. Intended Use
Collagen Dental Wound Dressings are indicated for the management of oral wounds and sores, including:
- Denture sores
- Oral ulcers (non-infected or viral) ●
- Periodontal surgical wounds ●
- Suture sites .
4
- Burns ●
- Extraction sites .
- Surgical wounds ●
- Traumatic wounds
6. Summary/Comparison of Technical Characteristics
Collagen Dental Wound Dressings have been determined to be substantially equivalent to the predicate devices having similar technological characteristics as follows:
| Parameter | Collagen Dental Wound
Dressings (This
submission) | Collagen Dental Wound
Dressing (Predicate,
K122115) | Dental Collagen Wound
Dressings (Predicate,
K142712) | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) | Not assigned | K122115 | K142712 | |
| Indications for
Use | Intended for use in the
management of oral
wounds and sores,
including:
• Denture Sores
• Oral Ulcers (non-
infected or viral)
• Periodontal surgical
wounds
• Suture sites
• Burns
• Extraction sites
• Surgical Wounds
• Traumatic Wounds | Intended for use in the
management of oral
wounds and sores,
including:
• Denture Sores
• Oral Ulcers (non-
infected or viral)
• Periodontal surgical
wounds
• Suture sites
• Burns
• Extraction sites
• Surgical Wounds
• Traumatic Wounds | Intended for use in the
management of oral
wounds and sores,
including:
• Denture Sores
• Oral Ulcers (non-
infected or viral)
• Periodontal surgical
wounds
• Suture sites
• Burns
• Extraction sites
• Surgical Wounds
• Traumatic Wounds | |
| Material | Purified Collagen | Purified Collagen | Purified Collagen | |
| Collagen
Source | Bovine Dermis | Porcine Tendon | Bovine Dermis | |
| Form | Porous Collagen Matrix | Porous Collagen Matrix | Porous Collagen Matrix | |
| Color | White to off-white | White to off-white | White to off-white | |
| Shapes | Rectangular and
Cylindrical | Rectangular and
Cylindrical | Rectangular and
Cylindrical | |
| Sizes | 25mm x 75mm x 1mm
20mm x 40mm x 3mm
10mm (ID) x 20mm (L) | 25mm x 75mm x 1mm
20mm x 40mm x 3mm
10mm (ID) x 20mm (L) | 25mm x 75mm x 1mm
20mm x 40mm x 3mm
10mm (ID) x 20mm (L) | |
| Absorbency | Absorbs local wound
fluids upon application | Absorbs local wound
fluids upon application | Absorbs local wound
fluids upon application | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Not Known | |
| Sterilization | Gamma Irradiation, SAL
10-6 | Gamma Irradiation, SAL
10-6 | E-beam irradiation, SAL
10-6 | |
| Single Use/
Reuse | Single use only | Single use only | Single use only | |
| Packaging | Single barrier (blister tray
or Tyvek pouch) | Single barrier (blister tray
or Tyvek pouch) | Single barrier (blister tray
or Tyvek pouch) | |
5
7. Discussion of Non-clinical Testing
The substantial equivalence of Collagen Dental Wound Dressings and its predicates was demonstrated based on in vitro characterization studies, biocompatibility studies and an animal resorption study.
Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as follows:
ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 1 Analysis and Risk Management
ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2 Controls on Sourcing, Collection, and Handling
ISO 22442-3 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 3 Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in vitro cvtotoxicity
ISO 10993-10:2009 Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization
Non-clinical Testing Conducted
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate devices. A series of bench tests were conducted which included an evaluation of physical, chemical, and biological properties as indicated.
| Test | Results |
|---|---|
| Composition | Purified Collagen |
| Dimensions | Dimensions similar to predicate device |
| Thickness | Thickness similar to predicate device |
| Density | Density similar to predicate device |
| Weight | Weight similar to predicate device |
| Absorbency | Absorbency similar to predicate device |
| Pyrogenicity | Non-Pyrogenic |
| Residues | Within acceptable limits |
| pH | pH similar to predicate device |
| Absorbency | Absorbency similar to predicate device |
| Hydrothermal | |
| transition temperature | Hydrothermal transition temperature similar to predicate |
| device. |
A series of in vitro and in vivo biocompatibility testing was performed to assess safety of the Collagen Dental Wound Dressings as a topical material. The biocompatibility testing performed is summarized in the table below.
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| Test | Test Method / Model | Results |
|---|---|---|
| Cytotoxicity | Agarose Overlay, ISO 10993-5 | |
| ISO Elution Method, ISO 10993-5 | Non-cytotoxic | |
| Sensitization | Guinea Pig Maximization, | |
| ISO 10993-10 | No evidence of causing delayed | |
| dermal contact sensitization in the | ||
| guinea pig. | ||
| Intracutaneous | ||
| Reactivity | Intracutaneous Study in Rabbits, | |
| ISO 10993-10 | Under the conditions of the study, | |
| there was no erythema or edema | ||
| from the extract injected | ||
| intracutaneously into rabbits. | ||
| Pyrogenicity | USP (151) Rabbit Pyrogen Study | The test article was judged as non- |
| pyrogenic. |
An in vivo resorption study utilizing a rat subcutaneous model was conducted to evaluate the device as compared to its predicate device with regards to device resorption.
A viral inactivation study was performed to ensure the viral safety of the product.
8. Conclusion of Non-clinical Studies
The predicate devices were cleared based on the results of non-clinical data. The results of the non-clinical tests conducted demonstrate that the device is substantially equivalent to the legally marketed predicate device.