The intended use of the Hanson Pectoralis Implant is augment or reconstruct the male chest by inserting the implant under the pectoralis muscle usually through a transaxillary incision. The proposed device can also be used for the correction of surface defects resulting from congenital anomalies such as depressions secondary to Poland's Syndrome. This product will be delivered non sterile.

Silicone Carving Blocks are to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle)

Device Description

The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer. The Chemical components of this device are polysiloxanes catalyzed by a two part system.

AI/ML Overview

The provided text is a 510(k) summary for the Hanson Medical Pectoralis implant. It states that the device is substantially equivalent to a predicate device, meaning it's similar enough to an existing legally marketed device that it does not require significant new testing or data.

Therefore, this document does not describe acceptance criteria for device performance or a study proving the device meets said criteria. Instead, it focuses on demonstrating equivalence to an already approved device based on material composition, manufacturing processes, and intended use.

Here's an explanation of why the requested information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not present. The submission focuses on equivalence rather than establishing new performance criteria.
Sample size used for the test set and the data provenance: Not applicable. No test set or performance data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review is mentioned for performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 silicone implant, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a silicone implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. This device does not involve a training set for an algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for substantial equivalence based on material and intended use similarity, not a performance study with acceptance criteria.

Summary

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Hanson Medical Inc. 19325 58th PL NE Seattle WA 98155 (425) 481 2185

DEC 2 4 1997

TAB G

1973729

510 (k) Summary

Substantial Equivalence

The Hanson Medical Pectoralis implant is Substantially Equivalent to the Allied Biomedical Pectoralis Implant. The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device.

Intended Use

Labeling

The labeling for this device will comprise a label for the inner package and a label for the outer box. Catalog numbers and sizes will be depicted on the labels. The package insert will contain instructions for use and sterilization. Product promotional literature will merely depict the sizes shapes and material hardness.

Physical and Chemical Properties

The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer.

The Chemical components of this device are polysiloxanes catalyzed by a two part system. Refer to master files MAF 562 of Applied and MAF 612 of Nusil for complete material characterizations.

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510(k) Summary Pectoralis Implants Continued.

Package Description

The implants will be packaged in a tyvec pouch and labeled with the size, cataloque number and dimensions. This inner package will be placed into a white thin paper box. This package will contain an outer label. This box will be properly cushion with bubble wrap and shipped in a corrugated box. Package inserts will be placed into the inner box and a packing slip will be placed in the shipping box.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathy Richardson Regulatory Affairs HANSON MEDICAL INC. 19325 58th Place N.E. Seattle, Washington 98155

DEC 2 4 1997

Re: K973729 Trade Name: Powerflex Pec Implant Regulatory Class: II Product Code: MIC Dated: September 27, 1997 Received: September 30, 1997

Dear Ms. Richardson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Kaathy Richardson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INTENDED USE FORM

Page 1 of 1

510 (k) Number (if known)

Device Name: Silicone Pectoralis Implant

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE) . . . .

Presecription Use
(Per 21 CFR 801.109)
OR
Over The Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
asion of General Restorative Devices
510(k) Nurhber K973729

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.