K Number

Validate with FDA (Live)

Device Name

HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS

Manufacturer

HUTCHISON INTL., INC.

Date Cleared

1999-03-15

(171 days)

Product Code

LCJ

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The HUTCHISON Inflatable Silicone Tissue Expanders are designed for use in:

. Scar/defect revision
Reconstruction of the breast following subcutaneous mastectomy and other suitable . procedures or trauma
Breast underdevelopment and combined breast and chest wall abnormalities .

Device Description

The HUTCHISON Inflatable Silicone Tissue Expander is currently manufactured and marketed in Europe. The HUTCHISON Inflatable Silicone Tissue Expanders will be sold in the US, sterile for single use only and in double-peel pouches to facilitate aseptic handling during implantation in the patient. Product packaging is designed to allow sterilization gases onto the product and permit proper degassing.

The Silicone Tissue Expanders are constructed from silicone elastomer and consist of a silicone connection tube and an injection site. The injection site is a self-sealing dome valve to allow for sterile saline injections for expanding the implant. The HUTCHISON Inflatable Silicone Tissue Expanders will be manufactured and available to physicians with two surface finishes, smooth or textured.

Hutchison Silicone Tissue Expanders are available in various designs and sizes to meet the patient and surgeon's needs. A more detailed description of size and volume is provided in Section 3. The available styles are:

. Round
Rectangle .
. Crescent
Cylindrical .
Croissant .
U design .

The manufacturer, Biosil Ltd., uses a high-strength silicone dispersion to produce the shell. The silicone materials used in producing the shell and the valve assembly have all received full biocompatibility assessment by the raw materials supplier.

Biosil has conducted extensive tests of the mechanical properties of the silicone shell and the fused joints, including the results from pre and post sterilization studies of elongation, tensile strength, tear resistance, and valve competence.

AI/ML Overview

The provided text is a 510(k) summary for the HUTCHISON Inflatable Silicone Tissue Expanders, submitted in 1998. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial acceptance criteria and performance data for a new device's accuracy or efficacy as one might find for, say, an AI diagnostic tool.

Therefore, many of the requested points regarding acceptance criteria, study design, statistical details, ground truth establishment, and expert involvement are not applicable to this type of regulatory submission concerning a physical medical device like a tissue expander.

However, I can extract information related to the device's characteristics and the validation activities that were performed to support its safety and performance.

Here's a breakdown of what can be inferred or directly stated from the provided text, and where gaps exist due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria in the way a diagnostic device would (e.g., sensitivity, specificity thresholds). Instead, for a physical implantable device like a tissue expander, "acceptance criteria" are implied by compliance with recognized standards regarding material properties, manufacturing processes, and sterilization.

Acceptance Criteria Category (Inferrred/Stated)	Reported Device Performance / Compliance
Material Biocompatibility	Silicone materials (shell and valve assembly) have received "full biocompatibility assessment by the raw materials supplier." This implies testing against established biocompatibility standards (e.g., ISO 10993).
Mechanical Properties (Silicone Shell & Fused Joints)	Biosil (manufacturer) "conducted extensive tests" of elongation, tensile strength, and tear resistance. These tests were performed "from pre and post sterilization studies." This indicates that mechanical integrity is maintained after sterilization. Specific numerical criteria and results are not provided in this summary.
Valve Competence	Biosil conducted "extensive tests" of valve competence. This suggests the self-sealing dome valve was tested to ensure it prevents leakage and allows for sterile saline injections. Specific numerical criteria and results are not provided.
Sterility Assurance Level (SAL)	The device is sterilized by the ethylene oxide method to provide an SAL of 10⁻⁶. This meets a widely accepted standard for sterile medical devices.
Manufacturing Environment	Implants are manufactured in a "clean room environment." This implies adherence to established cleanroom classification standards (e.g., ISO 14644).
Packaging	"Double-peel pouches to facilitate aseptic handling during implantation." "Designed to allow sterilization gases onto the product and permit proper degassing." This demonstrates consideration for maintaining sterility and ease of use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify a distinct "test set" sample size in the context of clinical performance data. The tests mentioned (mechanical properties, valve competence, biocompatibility) are typically performed on a representative sample of manufactured devices (e.g., batches of materials, finished products) as part of design validation and quality control, rather than on a "test set" of patients or a dataset of medical images.
Data Provenance: The manufacturing and testing are attributed to Biosil Ltd., the manufacturer, which suggests the data originates from their internal testing processes. The device is "currently manufactured and marketed in Europe," implying European regulatory compliance and data might originate there. The 510(k) is for marketing in the US, but the data is from the European manufacturer's validation efforts. The data described is in vitro or in-process testing, not clinical "patient" data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this 510(k) submission. The "ground truth" concept, in terms of expert consensus on diagnostic outcomes, is not relevant for a physical device like a tissue expander. The "truth" for this device lies in its material properties, mechanical performance, sterility, and biocompatibility, which are assessed by scientific and engineering tests, not clinical expert consensus on diagnostic findings.

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

This is not applicable. Adjudication methods are used in clinical studies with human readers / interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are laboratory/engineering tests (e.g., tensile strength, tear resistance, valve competence, biocompatibility), which would involve laboratory personnel following standardized protocols rather than a clinical adjudication process.

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

This is not applicable as this is a physical medical device (tissue expander), not an AI-powered diagnostic or assistive tool.

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

This is not applicable as this is a physical medical device, not an algorithm.

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

As described in point 3, the concept of "ground truth" in the clinical diagnostic sense is not applicable. The "ground truth" for this device's performance is established by:

Adherence to Material Specifications: Silicone materials meeting supplier's biocompatibility and property claims.
Validated Mechanical Properties: Achieving specific physical properties (e.g., tensile strength, elongation, tear resistance) as measured by standardized engineering tests.
Sterility Confirmation: Achieving a specified Sterility Assurance Level (SAL) through validated sterilization processes.
Functional Performance: Valve competence as demonstrated by testing.

8. The sample size for the training set

This is not applicable. Since this is a physical medical device and not an AI or diagnostic algorithm, there is no "training set" in this context.

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

This is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

3/15/99

K983385

510(K) SUMMARY EXHIBIT 1

. 23 Sept 1998

Submitter: Hutchison International Inc. 7949 Jefferson Hwy Baton Rouge, LA 70809 Telph: 504 927 6800 Fax: 504 927 6874

1. Classification Name:

Tissue Expanders Common Name: HUTCHISON Inflatable Silicone Tissue Expanders Proprietary Name:

Establishment Registration Number: 2. HUTCHISON INTERNATIONAL registration: 2320466
Device Classification: Tissue Expanders are unclassified. 3.
No performance standards have been established under section 514 4. Performance Standards: of the FD&C Act.

ર. Indications for Use:

The HUTCHISON Inflatable Silicone Tissue Expanders are designed for use in:

. Scar/defect revision
Reconstruction of the breast following subcutaneous mastectomy and other suitable . procedures or trauma
Breast underdevelopment and combined breast and chest wall abnormalities .

Device Description: 6.

{1}------------------------------------------------

. Round
Rectangle .
. Crescent
Cylindrical .
Croissant .
U design .

Biosil has conducted extensive tests of the mechanical properties of the silicone shell and the fused 7. joints, including the results from pre and post sterilization studies of elongation, tensile strength, tear resistance, and valve competence.

Sterility-

Biosil has all implants manufactured in a clean room environment and sterilized by the ethylene oxide method to provide a sterility assurance level (SAL) of 106 .

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Hutchison International, Inc. c/o Eduardo March, RAC Senior Consultant AAC Consulting Group, Inc. 7475 Wisconsin Avenue, Suite 850 Bethesda, Maryland 20814

Re: K983385

Trade Name: Hutchison Inflatable Silicone Tissue Expanders Regulatory Class: Unclassified Product Code: LCJ Dated: January 19, 1999 Received: January 20, 1999

Dear Mr. March:

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 requirement, as set forth in the Quality System Regulation (OS) 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.

{3}------------------------------------------------

Page 2 – Mr. Eduardo March

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

{4}------------------------------------------------

র্তা Page 1 1

510(k) Number (if known): K9g33385

Device Name: HUTCHISON Inflatable Silicone Tissue Expanders

Indications for Use:

The HUTCHISON Inflatable Silicone Tissue Expanders are designed for temporary use in:

Scar/defect revision .
Reconstruction of the breast following subcutaneous . mastectomy and other suitable procedures or trauma
Breast underdevelopment and combined breast and chest wall abnormalities ●

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: Use: (Per 21 CFR 80.109)

Over-the-Counter

coell

eral Restorative Devices K9833BS

Regulation Number and Section

N/A