The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists, in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.

Device Description

The Biodesign Nipple Reconstruction Cylinder is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material is identical to the predicates SurgiSIS® Mesh (K980431, K062696), SIS Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and available in sizes from 0.7 cm in diameter and 1.0 cm to 2.5 cm in length. The cylinder is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The device is implanted using a skin flap procedure that prevents migration of the device. A PET marking template (Class I, 21 CFR 888.4800) and silicone (35A durometer) nipple shield (Class I, 21 CFR 880.5630 ) to be placed over the cylinder post-operatively, are included with the device. The use of the Biodesign Nipple Recosntruction Cylinder, an off-the-shelf graft, is advantageous in that a donor site is no longer necessary.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Biodesign® Nipple Reconstruction Cylinder, based on the provided 510(k) summary:

This device's submission is for substantial equivalence to existing predicate devices, not for a de novo marketing authorization. Therefore, the "acceptance criteria" are not defined as specific performance thresholds, but rather the demonstration that the new device performs similarly to
its predicates across various tests, without raising new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be performance comparable to the predicate devices. The reported device performance is presented as demonstrating this comparability.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance
Suture Retention Strength	Performed similarly to predicate devices.
Ultimate Tensile Strength	Performed similarly to predicate devices.
Biocompatibility
Genotoxicity	Met biocompatibility requirements of ISO 10993-1.
Direct Contact In Vitro	Met biocompatibility requirements of ISO 10993-1.
Hemolysis
Cytotoxicity	Met biocompatibility requirements of ISO 10993-1.
Muscle Implantation	Met biocompatibility requirements of ISO 10993-1.
Acute Intracutaneous	Met biocompatibility requirements of ISO 10993-1.
Reactivity
ISO Sensitization	Met biocompatibility requirements of ISO 10993-1.
Acute Systemic Toxicity	Met biocompatibility requirements of ISO 10993-1.
Pyrogenicity	Met biocompatibility requirements of ISO 10993-1.
LAL Endotoxins	Met biocompatibility requirements of ISO 10993-1.
Subchronic Systemic Toxicity	Met biocompatibility requirements of ISO 10993-1.
Animal Performance
Tissue Integration/Response	Performed adequately with minimal inflammation and provided increased soft
	tissue volume at 5 months.
Clinical Performance
Equivalence in Application	Substantially equivalent to its predicates.
Complications	Device extrusion occurred (number not given).

2. Sample Sizes and Data Provenance

Bench Testing: The sample sizes for suture retention strength and ultimate tensile strength are not specified. The tests were performed on "finished, terminally sterilized SurgiSIS® mesh" which forms the device.
Biocompatibility Testing: The sample sizes for each specific biocompatibility test are not specified. The tests were performed on "sterilized SurgiSIS Mesh."
Animal Testing: The sample size is not explicitly stated beyond "an animal study" in "a guinea pig model." It is implied to include multiple animals to assess performance over 5 months.
- Data Provenance: The study was an animal study, likely conducted in a controlled laboratory setting. The country of origin is not specified but presumed to be within the Cook Biotech research facilities or contracted labs. The data is prospective within the context of the animal study.
Clinical Testing:
- Sample Size: 2 case studies and anecdotal evidence of 186 device implants (totaling 188 implants).
- Data Provenance: The document does not specify the country of origin. The data appears to be retrospective (anecdotal evidence from past implants) and possibly some prospective observation for the "2 case studies."

3. Number of Experts and Qualifications for Ground Truth for Test Set

This device's submission relies on demonstrating substantial equivalence to already approved predicate devices. Thus, there isn't a "test set" in the traditional sense of a diagnostic algorithm where expert ground truth is established for novel readings.

For the clinical testing, the "ground truth" implicitly comes from the clinical outcomes and observations made by the surgeons/clinicians performing the implants and follow-ups. The number of experts and their specific qualifications are not reported. Their assessment of "substantially equivalent to its predicates in its application" is based on their clinical experience.

4. Adjudication Method for the Test Set

Given the nature of the submission (substantial equivalence for a physical implant), there is no mention of an adjudication method in the context of expert review of data from a "test set" for a diagnostic algorithm. The clinical "data" comprises case studies and anecdotal evidence from implants managed by various clinicians.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported. This type of study is typical for diagnostic AI devices, not for assessing the substantial equivalence of a physical implant. The focus here is on the material, design, and performance characteristics compared to predicates.

6. Standalone Performance Study

This concept of "standalone performance" typically applies to diagnostic algorithms operating independently. Since this is a physical implant, it doesn't have a "standalone" algorithm-only performance. Its performance is assessed through its material properties, biological interaction (in animals), and clinical outcomes (in humans).

7. Type of Ground Truth Used

Bench Testing: The "ground truth" is based on objective mechanical measurements (suture retention strength, ultimate tensile strength) and comparison to established predicate device performance or industry standards.
Biocompatibility Testing: The "ground truth" is adherence to ISO 10993-1 standards for various biological responses.
Animal Testing: The "ground truth" is histopathological analysis and observation of tissue response (minimal inflammation, increased soft tissue volume) in the guinea pig model, compared to expected healthy tissue response and the known behavior of SIS material.
Clinical Testing: The "ground truth" is based on clinical outcomes, observations, and anecdotal evidence from patients who received the implant. This includes assessment of its ability to reinforce soft tissue in nipple reconstruction, functional outcomes, and reported complications. This is closer to outcomes data and expert clinical assessment rather than a single objective "ground truth" like pathology for a diagnostic image.

8. Sample Size for the Training Set

This submission does not involve a machine learning algorithm, so there is no "training set" in the context of AI. The development of the device (implant) relies on established knowledge of SIS material, previous predicate devices, and pre-clinical/clinical testing.

9. How Ground Truth for the Training Set was Established

As there is no training set for an AI model, this question is not applicable. The underlying "knowledge base" for the device's design and expected performance comes from decades of research and clinical use of SIS extracellular matrix material.

Summary

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510(k) Summary

June 15, 2011

Cook Biotech Incorporated

Biodesign® Nipple Reconstruction Cylinder

Manufacturer Name:

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709

Official Contact:

Perry W. Guinn

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Biodesign. Nipple Reconstruction Cylinder Surgical Mesh Class II, 21 CFR §878.3300 (FTM)

INTENDED USE:

DEVICE DESCRIPTION:

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The Biodesign Nipple Reconstruction Cylinder is identical to its predicates in terms of material (SIS), its rolled design (SurgiSIS, SIS Facial Implant [K070738]) and technology (its ability to be incorporated into the body). The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

EQUIVALENCE TO MARKETED DEVICES .

The Biodesign Nipple Reconstruction Cylinder is similar with respect to intended use, and identical with respect to materials and technological characteristics to the predicate devices in terms of section 510(k) substantial equivalence, as shown through bench (suture retention strength and ultimate tensile strength), animal, and biocompatibility testing (conducted in accordance to ISO 10993-1 standards) and clinical testing.

Bench testing

The following mechanical tests were performed on finished, terminally sterilized SurgiSIS® mesh that comprise the Biodesign Nipple Reconstruction Cylinder:

. Suture retention strength
Ultimate tensile strength .

The tests provided evidence that the Biodesign Nipple Reconstruction Cylinder performed similarly to its predicate devices.

Biocompatibility testing

The following biocompatibility tests were performed on sterilized SurgiSIS Mesh, which is identical in composition to the Biodesign Nipple Reconstruction Cylinder (according to the ISO 10993-1 standard):

Genotoxicity .
Direct contact in vitro hemolysis .
Cytotoxicity �
Muscle implantation �
Acute intracutaneous reactivity .
ISO Sensitization ●
Acute systemic toxicity
Pyrogenicity
LAL endotoxins .
Subchronic systemic toxicity .

The results of these tests provided evidence that the Biodesign Nipple Reconstruction Cylinder meets biocompatibility requirements of the ISO standard.

Animal testing

An animal study using finished devices of SIS, the same material that comprises the Biodesign Nipple Reconstruction Cylinder, in a guinea pig model showed that the

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device performed adequately with minimal inflammation and provided increased soft tissue volume at 5 months.

Clinical Testing

The clinical performance of the Biodesign Nipple Reconstruction Cylinder was assessed in 2 case studies and anecdotal evidence of 186 device implants. Of the 188 implants, complications included device extrusion (number of extrusions not given). Follow-up periods ranged from 2 to 12 months. The clinical studies showed the Biodesign Nipple Reconstruction Cylinder as substantially equivalent to its predicates in its application.

Substantial Equivalence

0.7 cm to 1.0 cm

Thickness

See Table 1 for a comparison of the subject device and its predicates.

Table 1 - Substantial Equivalence Comparison
Device	Biodesign NippleReconstruction Cylinder	SurgiSIS® Mesh	SIS Plastic SurgeryMatrix	SIS Facial Implant
Manufacturer	Cook BiotechIncorporated	Cook BiotechIncorporated	Cook BiotechIncorporated	Cook BiotechIncorporated
510(k) Number	Not assigned	K980431	K034039	K050246, K070738
Intended Use	For implantation toreinforce soft tissue,where weakness exists, inplastic and reconstructivesurgery of the nipple.	For implantation toreinforce soft tissue.	For implantation toreinforce soft tissue whereweakness exists inpatients requiring softtissue repair in plastic andreconstructive surgery.	For use to provide softtissue repair orreinforcement in plasticand reconstructivesurgery of the face andhead.
Material	Small intestinalsubmucosaPrimarily Types I, III, IVand VI collagen	Small intestinalsubmucosaPrimarily Types I, III, IVand VI collagen	Small intestinalsubmucosaPrimarily Types I, III, IVand VI collagen	Small intestinalsubmucosaPrimarily Types I, III, IVand VI collagen
Dimensions	0.7 cm to 1.0 cm diameter1.0 cm to 2.5 cm length	2 x 4 cm to 20 x 40 cm	0.2 cm to 7 cm x 20 cmlength	1.5 to 7 mm diameter5-15 cm length

Table 1 – Substantial Equivalence Comparison

CONCLUSION: The pre-clinical, animal and clinical tests performed on the Biodesign Nipple Reconstruction Cylinder show that the device is substantially equivalent to its predicates.

100 um -1500 um

0.1 mm to 1.5 mm

1.5 mm to 7 mm

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Cook BioTech, Inc. % Mr. Perry W. Guinn VP, Quality Assurance and Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906-1000

JUN 2 0 2011

Re: K110402

Trade/Device Name: Biodesign® Nippe Reconstruction Cylinder Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: June 9, 2011 Received: June 10, 2011

Dear Mr. Guinn:

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

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Page 2 - Mr. Perry W. Guinn

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Foll. Pete. Ramm m.o mm
Mark N. Melkerson
Oct. 15th Dr

Director Division of Surgical, Orthoped and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Biodesign® Nipple Reconstruction Cylinder Device Name:

Indications For Use:

The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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

Daniel Kraefer MEM

(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110402

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.