(290 days)
No
The device description and performance studies focus on the material properties and biological performance of a fish dermal matrix, with no mention of AI or ML.
Yes
The device is an implantable material used to aid in soft tissue and bone regeneration for various periodontal procedures, addressing medical conditions such as gingival defects, bone defects, and supporting Guided Tissue Regeneration.
No
Explanation: The device is an acellular resorbable fish dermal matrix intended for use in periodontal surgical procedures for soft tissue and bone regeneration. Its purpose is therapeutic and restorative, not diagnostic.
No
The device description clearly states it is an "acellular resorbable fish dermal matrix," which is a physical material, not software. The performance studies also focus on physical properties and biological interactions, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for soft tissue and bone regeneration in the oral cavity. These are therapeutic and reconstructive applications, not diagnostic tests performed in vitro (outside the body) on biological samples.
- Device Description: The device is a physical matrix intended to be implanted in the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information.
The device is clearly intended for surgical implantation and tissue regeneration, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
- Covering of implants placed in immediate extraction sockets;
- Covering of implants placed in delayed extraction sockets;
- Covering of bone defects after root resection and removal of retained teeth; and
- Guided tissue regeneration procedures in periodontal and recession defects.
Product codes
NPL
Device Description
The subject device is an acellular resorbable fish dermal matrix, intended for use in periodontal surgical procedures to aid in soft tissue and bone regeneration. It is obtained from cod fish skin by a standardized controlled manufacturing process, and supplied in terminally sterile peel-pouch packaging in the following solid sizes:
- 15mm x 20mm
- 20mm x 30mm
- 30mm x 40mm
It is biocompatible, non-cross linked, and therefore resorbable, strong, flexible, and supports fixation by sutures and pins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity, gingival tissue, bone defects (periodontal, recession, root resection, retained teeth, extraction sockets)
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
Bench testing was performed following FDA guidance, "Preparation of a Premarket Notification Application for a Surgical Mesh" (1999).
Performance studies conducted to verify material properties and support substantial equivalence:
- Morphology Observation: H&E staining and Scanning Electron Microscope (SEM) showed both subject and predicate devices are collagen-rich and porous, favoring cellular infiltration.
- Cellular ingrowth comparison: Both materials showed favorable cellular infiltration of fibroblasts after 14 days in in vitro cellular modes.
- Tensile Strength: Subject device's tensile strength was comparable to the predicate device.
- Heavy Metal Analysis: Limits of cadmium (Cd), lead (Pb), arsenic (As), and mercury (Hg) were acceptable under ICH guidelines: Q3D Elemental Impurities-Guidance for Industry.
- Dimensional Validation: Manufacturing dimensional validation on three lots showed dimensions and thickness met or exceeded quality limits (> 1.33).
- Stability in a simulated physiological environment: Subject device dissolved slower than the predicate device at neutral pH 7 in artificial saliva buffer.
- Suture Pull-Out Strength: Subject device meets or exceeds predicate with >95% confidence, per ANSI/AAMI/ISO 7198.
- Pin Pull-Out Strength: Subject device exceeds predicate with >95% confidence, per ASTM F-1839-08.
- Compression: Compressive Peak-Load, Load-at-Break, Probe Penetration-at-Break, and Energy-to-Break of subject device meet or exceed predicate with >95% confidence, per ASTM-F-1306.
- User Evaluation of Device for Cutting and Shaping: Favorable usability, substantially equivalent to predicate for cutting and shaping as a dental barrier membrane.
- Biocompatibility, Sterilization, Shelf-life and Animal origin:
- Biocompatibility per ISO 10993 series (Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute systemic toxicity, Subacute/sub-chronic toxicity, Genotoxicity, Implantation, Materials-Mediated Pyrogenicity, Chronic Toxicity, Carcinogenicity). Testing from K190528 and K153364 used to support.
- Sterilization validation per ISO 11737-1, Ethylene Oxide residual test following ISO 10993-7.
- Endotoxin validation ( 1.33
- Confidence levels for Suture/Pin Pull-Out and Compression: > 95%
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Kerecis Gudmundur Sigurjonsson CEO Eyrargata 2 Isafjordur, 400 Iceland
9/30/22
Re: K213904
Trade/Device Name: Kerecis® Oral Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: September 6, 2022 Received: September 7, 2022
Dear Gudmundur Sigurjonsson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213904
Device Name
Kerecis® Oral
Indications for Use (Describe)
- · Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
- · Covering of implants placed in immediate extraction sockets;
- · Covering of implants placed in delayed extraction sockets;
- · Covering of bone defects after root resection and removal of retained teeth; and
- · Guided tissue regeneration procedures in periodontal and recession defects.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Ke
510(k) Summary
Traditional Premarket Notification Submission (510(k)) Summary) Prepared in accordance with 21 CFR § 807.92
1. Submitter Information
| Sponsor Name: | Kerecis Limited |
|---|---|
| Sponsor Address: | Eyrargata 2 – PO Box 151, 400 Isafjordur, Iceland |
| Sponsor Telephone: | +011 354-419-8000 |
| Establishment Registration: | 301060025 |
| Primary Contact Person: | Gudmundur Fertram Sigurjonsson |
| Contact Title: | Founder, Chairman, President & CEO |
| Email Direct: | gfs@kerecis.com |
| Secondary Contact Person: | Daniel L. Mooradian, Ph.D. |
| Contact Title: | Senior VP for Research & Development |
| Email Direct: | dmooradan@kerecis.com |
| Additional Contact Person: | Jennifer Michelle Chambers, MPA, PMP, RAC |
| Contact Title: | Senior Regulatory Specialist |
| Email Direct: | jchambers@kerecis.com |
| Date Summary Prepared: | September 30, 2022 |
2. Device Information
| Trade Name (Proprietary): | Kerecis® Oral |
|---|---|
| Common (Usual): | Intraoral Surgical Graft |
| Classification Name: | Barrier, Animal Source, Intraoral |
| Device Classification: | Class II, 21 CFR § 872.3930 |
| FDA Device Code: | NPL |
3. Predicate Device and Reference Devices
Predicate Device Company Name: Ed. Geistlich Söhne Ag für Chemische Industrie MUCOGRAFT® Collagen Matrix Device Name (proprietary): K073711 Device 510(k):
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Reference Device Company Name: Device Name (proprietary): Device 510(k):
Kerecis Kerecis Gingiva Graft K192612
4. Device Description
The subject device is an acellular resorbable fish dermal matrix, intended for use in periodontal surgical procedures to aid in soft tissue and bone regeneration. It is obtained from cod fish skin by a standardized controlled manufacturing process, and supplied in terminally sterile peel-pouch packaging in the following solid sizes:
- 15mm x 20mm
- 20mm x 30mm
- . 30mm x 40mm
It is biocompatible, non-cross linked, and therefore resorbable, strong, flexible, and supports fixation by sutures and pins.
5. Intended Use
The subject device is indicated for:
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
- . Covering of implants placed in immediate extraction sockets;
- Covering of implants placed in delayed extraction sockets;
- Covering of bone defects after root resection and removal of retained teeth; and
- Guided tissue regeneration procedures in periodontal and recession defects.
6. Technological Characteristics and Substantial Equivalence
Comparison with the predicate device (K073711), and the reference device (K192612), demonstrate that it is substantially equivalent with regards to: intended use, materials, design, and operational principle.
See Table 6.1. Kerecis Oral is comparison with predicate and reference devices.
Table 6.1. Kerecis Oral is comparison with predicate and reference devices.
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Image /page/5/Picture/1 description: The image shows the word "Kerecis" in a stylized font. The letters are primarily dark blue, except for the "c" in the middle, which is orange. There is a registered trademark symbol to the right of the word.
| | Subject
Device | Predicate
Device | Reference
Device | Discussion |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Kerecis Oral | Geistlich
MUCOGRAFT
Collagen
Matrix | Kerecis
Gingiva Graft | N/A |
| 510(k) | TBD | K073711 | K192612 | N/A |
| Regulation | 21 CFR 872.3930 | 21 CFR 872.3930 | 21 CFR 872.3930 | Same regulation |
| Device Class | II | II | II | Same device class |
| Product Code | NPL | NPL | NPL | Same product code |
| Device
Classification | Barrier, Animal
Source, Intraoral | Barrier, Animal
Source, Intraoral | Barrier, Animal
Source, Intraoral | Same device classification |
| Intended Use | indicated for:
Localized
gingival
augmentation
to increase
keratinized
tissue (KT)
around teeth
or implants;
-Covering of
implants
placed in
immediate
extraction
sockets;
-Covering of
implants
placed in
delayed
extraction
sockets; | indicated for:
-Simultaneous
use of GBR-
membrane and
implants
-Covering of
implants
placed in
immediate
extraction
sockets;
-Covering of
implants
placed in
delayed
extraction
sockets;
-Localized ridge
augmentation | indicated for:
-Localized
gingival
augmentation
to increase
keratinized
tissue (KT)
around teeth
or implants. | Intended use includes
elements of the predicate and
reference devices, supported by
performance testing in canines,
intended to demonstrate
equivalence in the oral
environment |
| | | | | |
| | -Covering of
bone defects
after root
resection and
removal of
retained teeth;
-Guided tissue
regeneration
procedures in
periodontal
and recession
defects. | for later
implantation;
-Alveolar ridge
reconstruction
for prosthetic
treatment;
-Covering of
bone defects
after root
resection,
cystectomy,
removal of
retained teeth;
-Guided bone
regeneration in
dehiscence
defects; and
-Guided tissue
regeneration
procedures in
periodontal
and recession
defects. | | |
| Animal Origin
Material | Fish: skin
tissue, single
layer sheet | Porcine: skin
and connective
tissue, double
layer sheet | Fish: skin
tissue, single
layer sheet | Same animal species as
reference |
| Biocompatibility | Yes | Yes | Yes | Biocompatibility testing
performed per ISO 10993 series
standards |
| NON-Pyrogenic | Yes | Yes | Yes | Materials-mediated
pyrogenicity safe per ISO 10993
series standard |
| Tensile Strength | 14.3 MPa | 4.6 MPa | 14.3 MPa | Meets tensile strength value of
the predicate device per ASTM
D638 |
| Resorbable | Yes | Yes | Yes | All devices are resorbable per
comparative performance data |
| Sizes | 15x20 mm | 15x20 mm | 15x20 mm | Equivalent sizes by dimensional
analysis |
| | 20x30 mm | 20x30 mm | 20x30 mm | |
| | 30x40 mm | 30x40 mm | 30x40 mm | |
| Sterilization | Ethylene Oxide | Gamma
Irradiation | Ethylene Oxide | Traditional Sterilization Methods
per ISO 11135 and ISO 11737-1.
EO residual testing per
ISO 10993-7 |
| Sterility
Assurance Level | 10-6 | 10-6 | 10-6 | Equivalent SAL per ISO 11137
and ISO 11737 |
| Shelf Life | 3 years | 3 years | 3 years | Equivalent shelf life per ASTM
F1980 and Q5C (R2)[ICH] |
| Mode of Action | Fixation | Fixation | Fixation | Equivalent mode of action per
ANSI/AAMI/ISO 7198 and ASTM
F-1839-08 |
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Image /page/6/Picture/5 description: The image shows the word "Kerecis" in a bold, sans-serif font. The letters are primarily a dark blue color, except for the "c" in the middle of the word, which is a bright orange color. There is a registered trademark symbol to the right of the word.
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Image /page/7/Picture/1 description: The image shows the logo for Kerecis. The logo is in blue, except for the "c" in "cis", which is in orange. There is a registered trademark symbol to the right of the logo.
7.
Performance Testing - BenchBench testing was performed following FDA guidance,
"Preparation of a Premarket Notification Application for a Surgical Mesh" (1999). The following performance studies were conducted on representative product samples to verify that material properties remain unchanged and support substantial equivalence:
7.1 Morphology Observation
The subject device and the predicate device are based on the collagen rich animal tissue, piscine and porcine, respectively. Based on H&E staining, both materials are rich in collagen and porous, therefore favoring cellular infiltration. Scanning Electron Microscope (SEM) shows equivalent preserved collagen structure of the animal origin tissues used for both devices. Cross section of both devices showed that the porous surfaces in the skin derived collagen structure of both materials allows tissue adherence and promotes tissue regeneration by favoring cellular ingrowth when applied to soft tissue defect areas.
7.2. Cellular ingrowth comparison
Both materials were tested for cellular ingrowth capability by fibroblast seeding onto the materials in vitro cellular modes. Both materials showed favorable cellular infiltration of fibroblasts after 14 days
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Image /page/8/Picture/1 description: The image shows the word "Kerecis" in a stylized font. The letters are primarily dark blue, except for the "c" in the middle of the word, which is orange. A small registered trademark symbol is located to the upper right of the word.
which is a key component for tissue augmentation and re-epithelization of defected keratin tissue in the oral cavity.
7.3. Tensile Strength
The tensile strength of the subject device was determined to be comparable to the predicate device measured by ultimate tensile strength.
7.4. Heavy Metal Analysis
A heavy metal analysis was evaluated to show that the limits of cadmium (Cd), lead (Pb), arsenic (As) and mercury (Hg) contained within the subject device were acceptable under the ICH guidelines: Q3D Elemental Impurities-Guidance for Industry.
7.5. Dimensional Validation
Manufacturing dimensional validation was performed on three lots of the subject device where its dimension and thickness were tested. Kerecis has set the quality limits for a capability index to be > 1.33. All tested parameters met or exceeded the set goal.
7.6. Stability in a simulated physiological environment
A stability test was done in a simulated physiological oral environment (artificial saliva buffer) to investigate the dissolution of both material over time and to compare the effects that the products have on the pH levels and conductivity of the buffer over 24 hours. The subject device is structurally more stable than the predicate device since it dissolved slower than the predicate device at neutral pH 7.
7.7. Suture Pull-Out Strength
Consistent with recognized standard ANSI/AAMI/ISO 7198, The suture pull-out strength of the subject device meets or exceeds that of the predicate with a confidence of greater than 95%. The products are equivalent.
7.8. Pin Pull-Out Strength
Consistent with recognized standard ASTM F-1839-08, The pin pull-out strength of the subject device exceeds that of the predicate at a confidence level of greater than 95%. The products are equivalent.
7.9. Compression
In accordance with ASTM-F-1306, "Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates", the mechanical test for compressive strength was measured for the subject and predicate device. The compressive Peak-Load, Load-at-Break, Probe Penetrationat-Break, and Energy-to-Break of the subject device meet or exceed those of the predicate device, with a confidence of greater than 95%. The products are equivalent.
7.10. User Evaluation of Device for Cutting and Shaping
The subject device was evaluated in comparison to the predicate for use in the oral environment using a questionnaire. The results showed favorable usability that was substantially equivalent to the predicate for cutting and shaping the device for use as a dental barrier membrane.
7.11.Biocompatibility, Sterilization, Shelf-life and Animal origin.
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Image /page/9/Picture/1 description: The image shows the word "Kerecis" in a bold, sans-serif font. The letters are primarily dark blue, except for the "C" in the middle, which is a bright orange color. A small registered trademark symbol is located in the upper right corner of the image.
Testing from the applicant's own predicate device (K190528 and K153364) was used to s substantial equivalence.
Biocompatibility per ISO 10993 series
- · Cytotoxicity
- Sensitization
- Irritation or Intracutaneous reactivity
- · Acute systemic toxicity
- · Subacute/sub-chronic toxicity
- · Genotoxicity
- Implantation
- Materials-Mediated Pyrogenicity
- Chronic Toxicity
- Carcinogenicity
• Sterilization validation per ISO 11737-1, Ethylene Oxide residual test following ISO 10993-7
• Endotoxin validation (