SERI® Contour is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction.

Device Description

SERI® Contour is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from pure silk fibroin. The device is a mechanically strong and biocompatible protein mesh. SERI® Contour is a sterile, single use only product and is supplied in a variety of sizes. ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI® Contour provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (SERI® Contour) seeking substantial equivalence to a predicate device (SERI® Surgical Scaffold). As such, it focuses on demonstrating equivalence rather than establishing acceptance criteria against a defined clinical outcome or proving superiority. The information for a typical AI/software device performance study is not entirely available here because this is for a physical surgical mesh.

However, I will extract and infer the most relevant information based on the typical structure for a medical device efficacy study outlined in your request.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate)	Reported Device Performance (SERI® Contour)
Burst Strength	Exceed peak forces in the abdomen (specific numerical value not provided, but implied to be sufficient for abdominal pressure).	Verified to perform in excess of the maximum calculated, worst-case scenario of abdominal pressure. Equivalent to Scaffold at 3, 6, and 12-month evaluation in a large animal model.
Tissue Ingrowth	Supports tissue ingrowth.	Supported tissue ingrowth in a large animal model at 3, 6, and 12-month evaluation.
Biocompatibility	Biocompatible (based on predicate).	Same as predicate.
Sterilization	Sterilized (based on predicate).	Same as predicate.
Pliability/Drapability	(Implied: To meet clinical feedback for improved handling).	Increased pliability and drapability (due to larger pores and fully knitted mesh).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: "large animal model" – A specific number is not provided.
Data Provenance: Prospective (implied by "evaluated in a large animal model" and "in vivo performance testing"). Country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. This is a pre-clinical performance study in an animal model, not a human clinical trial where expert clinicians would establish ground truth for diagnosis/outcome.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. This refers to consensus among human readers for clinical ground truth, which is not relevant for this type of animal study.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh, not an AI/software diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this term is not applicable. The device is a physical surgical mesh.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth: For the animal study, the ground truth was based on direct measurements of mechanical properties (burst strength) and histological/microscopic evaluation for tissue ingrowth at specified time points (3, 6, and 12 months) in the large animal model. This is a form of direct measurement and pathological assessment.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set. The "design change" and "clinical feedback" could be considered analogous to iterative development, but not a formal 'training set' in the AI sense.

9. How the ground truth for the training set was established

Not applicable. (See #8).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2017

Sofregen Medical, Inc. Anh Hoang, Ph.D. Chief Scientific Officer 200 Boston Avenue. Suite 1100 Medford, MA 02155

Re: K172545

Trade/Device Name: SERI® Contour Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXF Dated: August 14, 2017 Received: August 23, 2017

Dear Dr. Hoang:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172545

Device Name SERI® Contour

Indications for Use (Describe)

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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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the SERI® Contour is provided below.

SUBMITTER 1.

Sofregen Medical, Inc. 200 Boston Avenue, Suite 1100 Medford, MA 02155

Contact Person: Anh Hoang, Ph.D. Phone: 781-874-2352 Email: anh@sofregenmedical.com Date Prepared: August 16, 2017

2. DEVICE

Name of Device: SERI® Contour Common Name: Surgical Mesh Classification Regulation: 21 CFR 878.3300 Regulatory Class: II Product Code: OXF Panel: General and Plastic Surgery

PREDICATE DEVICE 3.

Predicate Device: SERI® Surgical Scaffold (K123128)

Reference Device: None

DEVICE DESCRIPTION 4.

INDICATION FOR USE 5.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

The subject SERI® Contour has undergone a design change to increase the pore size and knit construction of the mesh compared to the predicate SERI® Surgical Scaffold (K123128). All other material and processing parameters are the same for the production and sterilization of Contour and Scaffold, independent of the pore size and knit pattern. The increased pore size of Contour and knitted construction in both material directions increase the mesh's elasticity that results in a more pliable and drapable surgical mesh. The design change updates handleability in response to clinical feedback, but maintain performance characteristics to accommodate soft tissue repair and support.

PERFORMANCE DATA 7.

The differences in surgical mesh specifications between Contour and Scaffold do not affect production, biocompatibility, and intended use of the product. Introducing greater pore area into the Contour design reduces overall density and burst strength of the mesh compared to the Scaffold predicate. Burst strength specifications for both devices were established to exceed peak forces in the abdomen. The fully knitted construction of Contour increases the elasticity and drapability of the mesh compared to Scaffold. When evaluated in a large animal model. Contour supported tissue ingrowth and equivalent burst strength to Scaffold at 3, 6, and 12month evaluation.

CONCLUSIONS 8.

The design change for SERI Contour introduces larger pores into a fully knitted mesh format, increasing both pliability and drapability requested from clinical feedback of SERI Scaffold. Independent of the mesh pattern, silk processing, mesh production, sterilization, biocompatibility, and intended use are identical to the predicate Scaffold surgical mesh. Burst stress for Contour was verified to perform in excess of the maximum calculated, worst case scenario of abdominal pressure. In vivo performance testing in a large animal model resulted in equivalent burst stress for Contour and Scaffold, confirming soft tissue formation through 1-year evaluation.

In conclusion, based on the same intended use and design change introducing larger pores in a fully knitted mesh, the subject SERI® Contour is substantially equivalent to the predicate SERI® Surgical Scaffold (K123128).

Regulation Number and Section

§ 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.