(286 days)
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
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.
The provided text describes a 510(k) premarket notification for "Collagen Dental Wound Dressings" (K152600). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a comparative effectiveness study or a comprehensive study with human readers.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" as would be set for a clinical trial with specific performance metrics (e.g., sensitivity, specificity for diagnostic devices, or specific clinical outcomes for therapeutic devices) are not explicitly stated in this 510(k) summary. Instead, the focus is on demonstrating "substantial equivalence" of the Collagen Dental Wound Dressings to its predicate devices by comparing technical characteristics and showing similar in vitro and in vivo performance in non-clinical tests.
The criteria for demonstrating substantial equivalence are implicitly that the new device performs comparably to the predicate devices in various tests.
| Parameter | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (Collagen Dental Wound Dressings) |
|---|---|---|
| Material | Purified Collagen (similar to predicate) | Purified Collagen |
| Collagen Source | Bovine Dermis (similar to K142712 predicate) / Porcine Tendon (K122115) | Bovine Dermis |
| Form | Porous Collagen Matrix (similar to predicate) | Porous Collagen Matrix |
| Color | White to off-white (similar to predicate) | White to off-white |
| Shapes | Rectangular and Cylindrical (similar to predicate) | Rectangular and Cylindrical |
| Sizes | Specific sizes (25x75x1mm, 20x40x3mm, 10mm(ID) x 20mm(L)) (similar) | Specific sizes (25x75x1mm, 20x40x3mm, 10mm(ID) x 20mm(L)) |
| Absorbency | Absorbs local wound fluids upon application (similar) | Absorbs local wound fluids upon application |
| Biocompatibility | Biocompatible (similar to predicate) | Biocompatible |
| Pyrogenicity | Non-pyrogenic (similar to K122115 predicate) | Non-pyrogenic |
| Cytotoxicity | Non-cytotoxic (similar to predicate expectations) | Non-cytotoxic |
| Sensitization | No evidence of causing delayed dermal contact sensitization | No evidence of causing delayed dermal contact sensitization |
| Intracutaneous Reactivity | No erythema or edema from the extract injected intracutaneously | No erythema or edema from the extract injected intracutaneously |
| Residues | Within acceptable limits (similar to predicate expectations) | Within acceptable limits |
| pH | pH similar to predicate device | pH similar to predicate device |
| Hydrothermal Transition Temp. | Hydrothermal transition temperature similar to predicate device | Hydrothermal transition temperature similar to predicate device |
| Viral Inactivation | Viral inactivation demonstrated (similar to predicate expectations) | Viral inactivation study performed |
| Resorption | Resorption profile comparable to predicate device (in animal model) | Resorption study conducted in rat model |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the samples used in the non-clinical tests (e.g., materials for in vitro characterization, animals for biocompatibility and resorption studies). The document does not specify exact sample sizes for each test. For example:
- In vitro characterization: The number of samples for each test (Composition, Dimensions, Thickness, Density, Weight, Absorbency, pH, Hydrothermal transition temperature) is not specified.
- Biocompatibility:
- Cytotoxicity: Not specified.
- Sensitization: "Guinea Pig Maximization" – typically involves a group of guinea pigs, but the exact number is not stated.
- Intracutaneous Reactivity: "Intracutaneous Study in Rabbits" – typically involves a group of rabbits, but the exact number is not stated.
- Pyrogenicity: "USP (151) Rabbit Pyrogen Study" – typically involves a few rabbits (e.g., 3-8), but the exact number is not stated.
- Resorption study: "rat subcutaneous model" – typically involves a group of rats, but the exact number is not stated.
- Viral inactivation study: Not specified how many samples/batches were tested.
Data Provenance: The data comes from non-clinical laboratory studies (in vitro and in vivo animal models). The document does not mention any human data (retrospective or prospective) for these tests. The country of origin for these specific tests is not stated but implied to be part of the manufacturer's R&D process, likely within the USA given the submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical testing. "Ground truth" established by human experts (e.g., radiologists, pathologists) is relevant for studies involving human data or diagnostic imaging. The "results" of these non-clinical tests are determined by standard laboratory methods and validated interpretations of those methods.
4. Adjudication Method for the Test Set
This information is not applicable for non-clinical laboratory testing. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies or studies evaluating diagnostic performance where independent reviewers assess cases, and discrepancies are resolved. The tests described here have objective outputs determined by the experimental protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the performance of human readers, sometimes with and without AI assistance, on a set of cases. The document describes a medical device (wound dressing) and its non-clinical characteristics, not a diagnostic or AI-enabled device requiring such a study.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this refers to a medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by the results of the standardized scientific tests themselves (e.g., an in vitro lab test concludes "Non-cytotoxic," an animal study shows "No evidence of causing delayed dermal contact sensitization"). These are objective measurements and observations determined by established methodologies rather than expert consensus, pathology reports (from human patients), or clinical outcomes data.
8. The Sample Size for the Training Set
This refers to a training set for machine learning models. Since this document is for a physical medical device (collagen wound dressings) and not an AI/ML product, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, this question is not applicable.
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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.
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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
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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 RoadOakland, New Jersey 07436 USA |
| Telephone: | (201) 405-1477 Ext. 317 |
| Fax: | (201) 405-1355 |
| Contact Person: | Gloria ZuclichDirector 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, CollagenProduct Code KGNUnclassified |
| 3. Legally Marketed Devices to Which Substantial Equivalence is Claimed | ||
|---|---|---|
| Primary Predicate: | K122115 Collagen Dental Wound DressingCollagen 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 .
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- 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 WoundDressings (Thissubmission) | Collagen Dental WoundDressing (Predicate,K122115) | Dental Collagen WoundDressings (Predicate,K142712) | |
|---|---|---|---|---|
| 510(k) | Not assigned | K122115 | K142712 | |
| Indications forUse | Intended for use in themanagement of oralwounds and sores,including:• Denture Sores• Oral Ulcers (non-infected or viral)• Periodontal surgicalwounds• Suture sites• Burns• Extraction sites• Surgical Wounds• Traumatic Wounds | Intended for use in themanagement of oralwounds and sores,including:• Denture Sores• Oral Ulcers (non-infected or viral)• Periodontal surgicalwounds• Suture sites• Burns• Extraction sites• Surgical Wounds• Traumatic Wounds | Intended for use in themanagement of oralwounds and sores,including:• Denture Sores• Oral Ulcers (non-infected or viral)• Periodontal surgicalwounds• Suture sites• Burns• Extraction sites• Surgical Wounds• Traumatic Wounds | |
| Material | Purified Collagen | Purified Collagen | Purified Collagen | |
| CollagenSource | 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 andCylindrical | Rectangular andCylindrical | Rectangular andCylindrical | |
| Sizes | 25mm x 75mm x 1mm20mm x 40mm x 3mm10mm (ID) x 20mm (L) | 25mm x 75mm x 1mm20mm x 40mm x 3mm10mm (ID) x 20mm (L) | 25mm x 75mm x 1mm20mm x 40mm x 3mm10mm (ID) x 20mm (L) | |
| Absorbency | Absorbs local woundfluids upon application | Absorbs local woundfluids upon application | Absorbs local woundfluids upon application | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Not Known | |
| Sterilization | Gamma Irradiation, SAL10-6 | Gamma Irradiation, SAL10-6 | E-beam irradiation, SAL10-6 | |
| Single Use/Reuse | Single use only | Single use only | Single use only | |
| Packaging | Single barrier (blister trayor Tyvek pouch) | Single barrier (blister trayor Tyvek pouch) | Single barrier (blister trayor Tyvek pouch) |
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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 |
| Hydrothermaltransition temperature | Hydrothermal transition temperature similar to predicatedevice. |
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 10993-5ISO Elution Method, ISO 10993-5 | Non-cytotoxic |
| Sensitization | Guinea Pig Maximization,ISO 10993-10 | No evidence of causing delayeddermal contact sensitization in theguinea pig. |
| IntracutaneousReactivity | Intracutaneous Study in Rabbits,ISO 10993-10 | Under the conditions of the study,there was no erythema or edemafrom the extract injectedintracutaneously 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.
N/A