(250 days)
No
The summary describes a biological mesh derived from fish skin and its mechanical and biological properties, with no mention of AI or ML in its function or manufacturing process.
No.
The device is described as a reinforcement for soft tissue, which is a structural rather than a therapeutic function.
No
The device is indicated for structural reinforcement of soft tissue, which is a therapeutic function, not a diagnostic one. It functions as a physical scaffold to repair weakness or defects.
No
The device description clearly states it is a physical fish skin medical device supplied in sterile packaging and describes bench and animal testing of its physical properties and performance, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for implantation to reinforce soft tissue during surgery. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is a fish skin medical device used for physical reinforcement. It's a physical implant, not something used to test samples from the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on mechanical properties (tensile strength, stiffness, etc.) and biocompatibility/tissue response in animal models, which are relevant to an implantable device, not a diagnostic test.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The subject device is indicated for: For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.
Product codes
OXH
Device Description
The subject device is a fish skin medical device indicated for physical reinforcement of a soft tissue defect or weakness.
The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular solid sizes:
- . 4x7 cm
- 7x10 cm
- 7x20 cm .
The subject device is biocompatible, non-crosslinked, and therefore resorbable, strong, flexible, and supports fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
- Bench testing was performed, following FDA guidance, "Preparation of a Premarket Notification Application for a Surgical Mesh" (1999), including but not limited to: tensile strength, suturability, hydration time test, thickness measurement, weight measurement, stiffness test (bend test), and microscopic structure analysis. All tests were performed on hydrated, sterile, ready-for-market devices, to confirm that the devices perform as expected under clinical conditions, and there were no negative effects on the mechanical properties.
- Animal testing was performed in a GLP laboratory, using the subject/test device and a control device. Based on the results of the study: the veterinarian's assessment of animal health (safety), the pathologist's assessment of the tissue response to the device (safety and efficacy), histology, and the in-vitro performance data tensile strength testing of the test and control explants side-by-side (efficacy), the performance of the subject device showed equivalence in safety and efficacy to that of the control device, when used to reinforce soft tissue defects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
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May 2, 2021
Kerecis Limited Gudmundur Sigurjonsson CEO Eyrargata 2 – PO Box 151 Isafjordur, 400 Iceland
Re: K202430
Trade/Device Name: Kerecis Reconstruct Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXH Dated: March 25, 2021 Received: April 1, 2021
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.
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
1
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 mediation-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,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202430
Device Name
Kerecis Reconstruct
Indications for Use (Describe)
The subject device is indicated for:
For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.
| Type of Use (Select one or both, as applicable) | ☑ Reproductive Use (Part 21 CFR 321.1 Subject to Phase 1) ☐ Non-Therapeutic Use (21 CFR 321.1 Subject to Phase 1) | ☑ Reproductive Use (Part 21 CFR 321.1 Subject to Phase 1) | ☐ Non-Therapeutic Use (21 CFR 321.1 Subject to Phase 1) |
|---|---|---|---|
| ☑ Reproductive Use (Part 21 CFR 321.1 Subject to Phase 1) | |||
| ☐ Non-Therapeutic Use (21 CFR 321.1 Subject to Phase 1) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Kerecis® Reconstruct Volume 05: 510(k) Summary
Image /page/3/Picture/1 description: The image shows the logo for "Kerecis" in a dark blue font, with the "c" in the middle of the word in orange. Above the logo, the text "K202430 Page 1 of 5" is displayed. The logo is simple and modern, with a focus on the company name.
Volume 05: 510(k) Summary
Traditional Premarket Notification Submission (510(k)) Summary) Prepared in accordance with 21 CFR § 807.92
5.1 Submitter Information
| Sponsor Name: | Kerecis Limited |
|---|---|
| Sponsor Address: | Eyrargata 2 - PO Box 151, 400 Isafjordur, Iceland |
| Sponsor Telephone: | +354-419-8000 |
| Establishment Registration: | 301060025 |
| Contact Person: | Gudmundur Fertram Sigurjonsson |
| Contact Title: | Chairman |
| Email Direct: | gfs@kerecis.com |
| Date Summary Prepared: | March 19, 2021 |
5.2 Device Information
| Trade Name (proprietary): | Kerecis Reconstruct |
|---|---|
| Common (usual): | Surgical Graft |
| Device Classification: | Class II, 21 CFR § 878.3300 |
| FDA Device Code: | OXH |
5.3 Predicate Device and Reference Devices
| Predicate Device | |
|---|---|
| Company Name: | Cook Biotech Inc. |
| Device Name (proprietary): | Biodesign Plastic Surgery Matrix |
| Device 510(k): | K191696 (K161221, K034039) |
| Reference Device #1 | |
| Company Name: | Kerecis |
| Device Name (proprietary): | Kerecis SecureMesh |
| Device 510(k): | K153364 |
4
Kerecis Reconstruct Volume 05: 510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for "Kerecis" in a dark blue font, with the "c" in the middle of the word in orange. To the left of the logo is the text "K202430 Page 2 of 5". The logo is simple and modern, and the use of color makes it visually appealing. The logo is likely used to represent the company and its brand.
Reference Device #2 Company Name: Device Name (proprietary): Device 510(k):
Cook Biotech Inc. Biodesign Hernia Graft K133306
5.4 Device Description
The subject device is a fish skin medical device indicated for physical reinforcement of a soft tissue defect or weakness.
The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular solid sizes:
- . 4x7 cm
- 7x10 cm
- 7x20 cm .
The subject device is biocompatible, non-crosslinked, and therefore resorbable, strong, flexible, and supports fixation.
5.5 Intended Use
The subject device is indicated for:
- a For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.
5.6 Technological Characteristics
Comparison of the subject device with predicate device (K191696), and the reference devices (K153364 and K133306), demonstrate that it is substantially equivalent with regards to: intended use, materials, design, and operational principle.
5.7 Summary of Supporting Evidence for Substantial Equivalence
- . Analysis of 510(k) Substantial Equivalence Decision-Making Process as outlined in FDA's Guidance Document, the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
- . Bench testing was performed, following FDA guidance, "Preparation of a Premarket Notification Application for a Surgical Mesh" (1999), including but not limited to: tensile strength, suturability, hydration time test, thickness measurement, weight measurement, stiffness test (bend test), and microscopic structure analysis. All tests were performed on hydrated, sterile, ready-for-market devices, to confirm that the devices perform as expected under clinical conditions, and there were no negative effects on the mechanical properties.
5
Image /page/5/Picture/1 description: The image shows the logo for "Kerecis" in a bold, sans-serif font. The letters are primarily in a dark blue color, except for the "C" in the middle, which is in a bright orange color. Above the logo, the text "K202430 Page 3 of 5" is displayed in a smaller, regular font.
- . Animal testing was performed in a GLP laboratory, using the subject/test device and a control device. Based on the results of the study: the veterinarian's assessment of animal health (safety), the pathologist's assessment of the tissue response to the device (safety and efficacy), histology, and the in-vitro performance data tensile strength testing of the test and control explants side-by-side (efficacy), the performance of the subject device showed equivalence in safety and efficacy to that of the control device, when used to reinforce soft tissue defects.
5.8 Summary Table of Substantial Equivalence
A comparison of the subject device, predicate device, and two (2) reference devices are presented in TABLE 5-1.
| | Subject Device | Predicate
Device | Reference
Device | Reference
Device | Discussion |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Company | Kerecis | Cook Biotech | Kerecis | Cook Biotech | No discussion
required |
| Name | Kerecis
Reconstruct | Biodesign
Plastic Surgery
Matrix | Kerecis
SecureMesh | Biodesign
Hernia Graft | No discussion
required |
| 510(k) | Subject Device | K191696 | K153364 | K133306 | Predicate &
Reference devices
are all legally
marketed in the
USA |
| Device
Classification | II | II | II | II | Identical |
| Regulation | 21 CFR 878.3300 | 21 CFR 878.3300 | 21 CFR 878.3300 | 21 CFR 878.3300 | Identical |
| Product
Code | OXH | FTM, OXH | OXE | FTM, OXK | Product Code of
subject is a subset
of the predicate |
| Intended
Use | to reinforce soft
tissue where
weakness exists
in patients
requiring soft
tissue repair or
reinforcement in
plastic or
reconstructive
surgery | to reinforce soft
tissue where
weakness exists
in patients
requiring soft
tissue repair or
reinforcement in
plastic or
reconstructive
surgery | to be used as a
staple line
buttress | to reinforce soft
tissue where
weakness exists | Intended Use is
identical for the
subject &
predicate |
| Indications
for Use | Indications for
use include soft
tissue repair or | Indications for
use include soft
tissue repair or | Reinforcement
of staple lines
during: | Indications for
use include the
repair of hernia | Indications for Use
are identical for
the subject & |
| | reinforcement in
plastic or
reconstructive
surgery. The
graft is supplied
sterile and is
intended for
one-time use. | reinforcement in
plastic or
reconstructive
surgery. The
graft is supplied
sterile and is
intended for
one-time use. | 1.
Bariatric
surgical
procedures
2.
Gastric,
small
bowels and
mesentery
procedures
3.
Colorectal
and colon
procedures
4.
Lung and
bronchus
resections | or body wall
defects. The
graft is supplied
sterile and is
intended for
one-time use. | predicate (Note:
the subject device
adds example
procedures for
clarification) |
| Material | Atlantic Cod Fish | Porcine | Atlantic Cod Fish | Porcine | Identical material
to reference
device |
| Shapes | Rectangular | Rectangular | Custom design
for surgical
staplers | Rectangular | Subject device is
rectangular or
shredded. Either
configuration is
provided sterile in
a Tyvek pouch. |
| Size | 4x7 cm
7x10 cm
7x20cm | 4x7 cm
7x10 cm
7x20 cm | Multiple sizes
for FDA cleared
surgical staplers | 5x8cm to
30x30cm | Subject device
sizes are identical
to the predicate
device. |
| Surface Area | Maximum
140cm² | Maximum
140cm2 | Maximum
600cm2 | Maximum
900cm2 | Subject surface
area is within
range of SIS
devices |
| Operating
Principle | Supports
fixation by
sutures, tacks,
or staples | Supports
fixation by
sutures, tacks,
or staples | Supports
fixation by
sutures, tacks,
or staples | Supports
fixation by
sutures, tacks,
or staples | Identical |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf-Life | 3 years | 1.5 years | 3 years | 3 years | Identical to
reference devices |
| Requires Re-
hydration? | Yes | Yes | Yes | Yes | Identical |
6
Image /page/6/Picture/1 description: The image shows the Kerecis logo in blue and orange. The logo is a stylized version of the company name, with the "C" in "Kerecis" being orange. Above the logo, the text "K202430 Page 4 of 5" is visible, indicating this is a page from a document.
7
Image /page/7/Picture/1 description: The image shows the Kerecis logo in blue and yellow. The logo is a stylized wordmark with the letters "k," "e," "r," "e," "c," "i," and "s." The "c" in "Kerecis" is colored yellow, while the rest of the letters are blue. Above the logo, the text "K202430 Page 5 of 5" is visible.
5.9 Conclusion
The data provided within this submission support substantial equivalence of the subject device to the predicate device with regards to intended use, technological characteristics including principles of operation, performance characteristics, and device safety.
For use in reinforcement of plastic surgery soft tissue defects, Kerecis Reconstruct is safe, effective, and substantially equivalent to the predicate device.