(250 days)
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.
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.
The provided document is a 510(k) summary for a medical device called "Kerecis Reconstruct," which is a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical effectiveness studies with explicit acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement. Therefore, the information requested in the prompt, which is typical for AI/ML-based diagnostic devices, is not directly available in this document for the Kerecis Reconstruct device.
However, I can extract the information that is present, particularly regarding the studies and comparisons performed to demonstrate substantial equivalence, which serves a similar purpose to meeting "acceptance criteria" in the context of a 510(k) submission for this type of device.
Here's an analysis based on the provided text, structured to address your points where possible, and noting where the information is not applicable or not provided.
Device: Kerecis Reconstruct (Surgical Mesh)
1. Table of Acceptance Criteria and Reported Device Performance
For a surgical mesh, the "acceptance criteria" for 510(k) clearance are primarily focused on demonstrating that the new device is as safe and effective as a predicate device, based on similar technological characteristics and performance. Formal quantitative performance metrics (like sensitivity/specificity for AI, or specific effect sizes for human reader improvement) are not typically applicable or reported for this type of device in a 510(k) summary in the same way they would be for an AI diagnostic algorithm.
Instead, the "acceptance criteria" implicitly relate to meeting similar material properties, functional performance (e.g., tensile strength, suturability), and biocompatibility as the predicate device. The "reported device performance" is demonstrated through bench testing and animal studies, showing equivalence.
| Acceptance Criteria (Implicit for Surgical Mesh Equivalence) | Reported Device Performance (as summarized) |
|---|---|
| Biocompatibility & Safety: Safe tissue response, no adverse effects. | Animal testing in a GLP laboratory showed: - Veterinarian's assessment of animal health (safety) was equivalent. - Pathologist's assessment of tissue response (safety and efficacy) was equivalent. |
| Material Properties: Similar physical and mechanical properties to predicate (e.g., non-crosslinked, resorbable, strong, flexible). | Described as biocompatible, non-crosslinked, resorbable, strong, and flexible. Derived from cod fish skin (similar to predicate being porcine). |
| Mechanical Performance: Equivalent functional characteristics (e.g., tensile strength, suturability, stiffness, hydration). | Bench testing (tensile strength, suturability, hydration time, thickness, weight, stiffness/bend test, microscopic structure) performed on hydrated, sterile, ready-for-market devices confirmed performance as expected. - Specific quantitative values for these tests are not provided in the summary. - In-vitro performance data tensile strength testing of the test and control explants side-by-side (efficacy) showed equivalence. |
| Intended Use Compatibility: Works for reinforcing soft tissue in plastic/reconstructive surgery. | Predicate device's intended use is identical: "to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery." Subject device claims identical intended use. |
| Sterility & Shelf Life: Meets established standards. | Sterilization Method: Ethylene Oxide (identical to predicate/references). Shelf-Life: 3 years. Predicate was 1.5 years, but reference devices were 3 years. This seems to be accepted. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated numerically for the bench testing. The animal study involved at least one "test device" (Kerecis Reconstruct) and a "control device," but the number of animals/samples is not specified in this summary.
- Data Provenance:
- Bench testing: Performed internally or by a testing laboratory as part of the submission per FDA guidance.
- Animal testing: Performed in a "GLP laboratory" (Good Laboratory Practice). The origin (country/retrospective/prospective) is not specified, but GLP implies a prospective, controlled study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission for a non-diagnostic medical device. "Ground truth" in this case is established through objective physical measurements (bench testing) and histological/veterinary assessments in the animal model. The animal study mentions a "veterinarian's assessment" and a "pathologist's assessment," but the number and specific qualifications (beyond "veterinarian" and "pathologist") are not provided.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers/interpreters needing adjudication. The evaluation relies on objective physical/mechanical tests and expert animal health and pathology assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
Not applicable. This device is a surgical mesh, not an AI diagnostic tool or an imaging product that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
- For bench testing: Established by validated testing methods against industry standards or direct comparison to the predicate device. This is essentially objective physical and mechanical property measurement.
- For animal study: Established by GLP-compliant veterinary examination and histopathological analysis. This can be considered a form of "pathology" ground truth for tissue response and "outcomes data" for animal health.
8. The Sample Size for the Training Set
Not applicable. This is a manufactured medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary of what the document does provide regarding the "study that proves the device meets the acceptance criteria" (i.e., demonstrates substantial equivalence):
The submission for Kerecis Reconstruct justifies substantial equivalence to the predicate device (Biodesign Plastic Surgery Matrix, K191696) and reference devices (Kerecis SecureMesh K153364, Biodesign Hernia Graft K133306) through:
- Analysis of 510(k) Substantial Equivalence Decision-Making Process: Following FDA's guidance document.
- Bench Testing: Performed according to FDA guidance "Preparation of a Premarket Notification Application for a Surgical Mesh" (1999). Tests included: tensile strength, suturability, hydration time, thickness, weight, stiffness (bend test), and microscopic structure analysis. These tests were performed on hydrated, sterile, ready-for-market devices. The summary states these tests "confirmed that the devices perform as expected under clinical conditions, and there were no negative effects on the mechanical properties."
- Animal Testing: Performed in a GLP laboratory using the subject device and a control device. The results demonstrated "equivalence in safety and efficacy" to the control device, based on:
- Veterinarian's assessment of animal health (safety).
- Pathologist's assessment of the tissue response to the device (safety and efficacy).
- Histology.
- In-vitro performance data (tensile strength testing of the test and control explants side-by-side) (efficacy).
The document concludes that 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."
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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
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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
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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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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 |
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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.
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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 | PredicateDevice | ReferenceDevice | ReferenceDevice | Discussion | |
|---|---|---|---|---|---|
| Company | Kerecis | Cook Biotech | Kerecis | Cook Biotech | No discussionrequired |
| Name | KerecisReconstruct | BiodesignPlastic SurgeryMatrix | KerecisSecureMesh | BiodesignHernia Graft | No discussionrequired |
| 510(k) | Subject Device | K191696 | K153364 | K133306 | Predicate &Reference devicesare all legallymarketed in theUSA |
| DeviceClassification | II | II | II | II | Identical |
| Regulation | 21 CFR 878.3300 | 21 CFR 878.3300 | 21 CFR 878.3300 | 21 CFR 878.3300 | Identical |
| ProductCode | OXH | FTM, OXH | OXE | FTM, OXK | Product Code ofsubject is a subsetof the predicate |
| IntendedUse | to reinforce softtissue whereweakness existsin patientsrequiring softtissue repair orreinforcement inplastic orreconstructivesurgery | to reinforce softtissue whereweakness existsin patientsrequiring softtissue repair orreinforcement inplastic orreconstructivesurgery | to be used as astaple linebuttress | to reinforce softtissue whereweakness exists | Intended Use isidentical for thesubject &predicate |
| Indicationsfor Use | Indications foruse include softtissue repair or | Indications foruse include softtissue repair or | Reinforcementof staple linesduring: | Indications foruse include therepair of hernia | Indications for Useare identical forthe subject & |
| reinforcement inplastic orreconstructivesurgery. Thegraft is suppliedsterile and isintended forone-time use. | reinforcement inplastic orreconstructivesurgery. Thegraft is suppliedsterile and isintended forone-time use. | 1.Bariatricsurgicalprocedures2.Gastric,smallbowels andmesenteryprocedures3.Colorectaland colonprocedures4.Lung andbronchusresections | or body walldefects. Thegraft is suppliedsterile and isintended forone-time use. | predicate (Note:the subject deviceadds exampleprocedures forclarification) | |
| Material | Atlantic Cod Fish | Porcine | Atlantic Cod Fish | Porcine | Identical materialto referencedevice |
| Shapes | Rectangular | Rectangular | Custom designfor surgicalstaplers | Rectangular | Subject device isrectangular orshredded. Eitherconfiguration isprovided sterile ina Tyvek pouch. |
| Size | 4x7 cm7x10 cm7x20cm | 4x7 cm7x10 cm7x20 cm | Multiple sizesfor FDA clearedsurgical staplers | 5x8cm to30x30cm | Subject devicesizes are identicalto the predicatedevice. |
| Surface Area | Maximum140cm² | Maximum140cm2 | Maximum600cm2 | Maximum900cm2 | Subject surfacearea is withinrange of SISdevices |
| OperatingPrinciple | Supportsfixation bysutures, tacks,or staples | Supportsfixation bysutures, tacks,or staples | Supportsfixation bysutures, tacks,or staples | Supportsfixation bysutures, tacks,or staples | Identical |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf-Life | 3 years | 1.5 years | 3 years | 3 years | Identical toreference devices |
| Requires Re-hydration? | Yes | Yes | Yes | Yes | Identical |
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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.
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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.
§ 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.