Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers, and other short term uses according to the surgeon's determination.

Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, dural covering .005 inch, nasal septal repair, tendon anastomosis, neural repair - . 007 inch. correction of strabismus .010 inch, repair - . 020 inch, orbital floor repair . 040inch, galea hemodialysis shunt anchors .060. Reinforced - Facilitation of osteogenesis . 007inch, repair of urethral strictures . 007inch, staged repair of omphalocoel .020inch, repair of orbital floor fractures .040inch.

Device Description

Durasil I and Durasil II Silicone Elastomer Sheeting are made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone and Nusil Technologies' MED 4750. There is essentially no difference between these two products saving for the short term and long term indications which are for marketing considerations only. Durasil I and II are available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 607.

AI/ML Overview

The provided text describes a 510(k) submission for Durasil Sheeting, which is a silicone elastomer product. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting evidence in the way a contemporary AI/Software as a Medical Device submission would.

Therefore, for aspects like "reported device performance," "sample size," "experts used," "adjudication method," "MRMC study," "standalone study," or "training set details," the information is not applicable in this context, as these are typically part of a clinical performance study for a new device's efficacy, not a substantial equivalence submission for a material.

Here's how to break down the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (Durasil Sheeting)
Material Composition	- Made from biocompatible silicone high consistency rubber. - Materials meet or exceed Class VI USP Standards for biocompatibility (including Teratogenicity, Mutagenicity, Carcinogenicity, Toxicity Testing). - Consistent with materials used in predicate device (Duralastic I and II).	- Made from HCRP-50 (Applied Silicone) and MED 4750 (Nusil Technologies), both biocompatible silicone high consistency rubbers. - Materials meet FDA Biocompatibility Guidelines and exceed/meet Class VI USP Standards (Teratogenicity, Mutagenicity, Carcinogenicity, and Toxicity Testing). Referenced in Applied Master File - MAF 607 and Nusil Master File MAF 500. - Chemically, Durasil II is dimethylpolysiloxane.
Manufacturing Process	- Same manufacturing processes as predicate device.	- "Made from the same materials using the same processes" as predicate device. It is a "vulcanized calendared cured rubber."
Physical Properties	- Consistent physical properties (hardness, elongation, tensile strength, tear strength, specific gravity) with predicate device.	- Hardness: 45-55 Durometer (Shore A). - Elongation: 800 percent. - Tensile Strength: 1600 psi. - Tear Strength: 190 psi (Tear Die C). - Elasticity: Greatly reduced in polyester reinforced sheets. - Specific Gravity: 1.16. - Details referenced in Masterfile MAF 607 (Applied Silicone) and MAF 500 (Nusil Technologies).
Device Size and Thickness	- Same sizes and thicknesses as predicate device.	- "Made in the same sizes and thicknesses" as predicate device. Mentioned specific thicknesses in "Intended Uses" for Durasil II (e.g., .005 inch, .007 inch, .010 inch, .020 inch, .040 inch, .060 inch).
Intended Use	- Same intended uses (short-term and long-term applications) as predicate device.	- Durasil I (Short Term): Nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, guided tissue regeneration between teeth and gingival margin, external ear canal, temporary joint spacers, and other short-term uses. - Durasil II (Long Term): - Nonreinforced: Tympanic membrane repair, dural covering, nasal septal repair, tendon anastomosis, neural repair, correction of strabismus, orbital floor repair, galea hemodialysis shunt anchors. - Reinforced: Facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel, repair of orbital floor fractures.
Sterilization	- Validated sterilization cycle.	- Sterilized via gamma radiation 2.5 - 4.2 Megarads. - Validation by STI Corporation (Brea, CA) using Method 1 Testing as defined in ANSI/AAMI/ISO 11137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization."

Study Proving Device Meets Acceptance Criteria:

The primary "study" in a 510(k) submission for substantial equivalence is a comparison to a legally marketed predicate device.

Substantial Equivalence Statement: The claim is that "These products are substantially equivalent to Duralastic I and II made by Allied Biomedical's Sheeting (K971480). Because Durasil Sheeting is made from the same materials using the same processes and made in the same sizes and thicknesses for the same intended use, it is SE to the predicate devices."

This is not a traditional scientific study with experimental results in the sense of a clinical trial. Instead, it's a demonstration that the new device (Durasil Sheeting) is as safe and effective as a device already on the market (Duralastic I and II) through direct comparison of materials, manufacturing, physical properties, dimensions, and intended uses.

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

Not Applicable. This is a substantial equivalence submission based on material and design comparison, not a clinical performance test set. The "data" used is a direct comparison of specifications and intended use to the predicate device.

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)

Not Applicable. Ground truth, in the context of device performance studies, is not established for this type of submission. The "truth" is established by the accepted specifications and performance of the predicate device.

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

Not Applicable. No test set or adjudication method is described.

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 is a physical medical device (silicone sheeting), not an AI or imaging device 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 is a physical medical device, not an algorithm.

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

Comparative Basis / Predicate Device Specifications: The "ground truth" for this submission is the established safety and efficacy, and the detailed specifications (material, physical properties, manufacturing process, intended use, sterilization validation) of the legally marketed predicate device (Duralastic I and II, K971480).

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not Applicable. See point 8.

Summary

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K973730

HANSON MEDICAL INC. 19325 58TH PL. NE. Seattle WA 98155 (425) 481 2185 510(k) Submission Durasil Sheeting

DEC 2 4 1997

TAB H

510 (K) SUMMARY

PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

These products are substantially equivalent to Duralastic I and II made by Allied Biomedical's Sheeting (K971480). Because Durasil Sheeting is made from the same materials using the same processes and made in the same sizes and thicknesses for the same intended use, it is SE to the predicate devices.

INTENDED USES

Durasil I and II are intended for a variety of medical purposes both in short term and long term applications. For short term application this list includes nasal splinting, wound dressings, scar coverings, temporary joint shims, and laboratory uses. For long term use this list includes nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair, staged repair of omphalocoel, lengthening of extraocular muscles, tendon and nerve anastomosis, facilitation of osteogenesis or guided tissue regeneration, and other uses deemed appropriate by the using surgeon. Silicone sheeting has been in use for over 30 years and the uses are myriad. Hanson Medical Inc. advises surgeons to consult the literature before utilizinq

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TAB H 510(k) Summary

Durasil Sheeting for any purpose in the package inserts.

PHYSICAL AND CHEMICAL PROPERTIES

Durasil Sheeting is a vulcanized calendared cured rubber of a 45 -55

Durometer hardness (Shore A). It has an elonqation of 800 percent with a tensile strength of 1600 psi and a tear strength of 190 psi (Tear Die C). The elasticity is greatly reduced in the polyester reinforced sheets. The specific gravity is 1.16. Chemically Durasil II are made from HCRA-50, an Applied and a I Silicone dimethylpolysiloxane and from Nusil Technologies MED 4750. For details on the foregoing chemical and physical properties consult Masterfile MAF 607 of Applied Silicone and MAF 500 of Nusil Technoloqies.

STERILIZATION CYCLE

Durasil I and II sheeting are sterilized via gamma radiation 2.5 -4.2 Megarads. The validation of this cycle was performed by STI Corporation of Brea California. STI uses Sterigenics Inc. as the contract gamma radiation sterilizer. The validation uses Method 1 Testing as defined in the ANSI/AAMI/ISO 11137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization."

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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 consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 1997

Mr. Gerald Hanson Regulatory Affairs HANSON MEDICAL INC. 19325 58th Place NE Seattle, Washington 98155

Re: K973730 Trade Name: Durasil I and Durasil II Regulatory Class: Unclassified Product Code: MIB Dated: September 27, 1997 Received: September 30, 1997

Dear Mr. Hanson:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Gerald Hanson

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

If you desire specific advice for your devices 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 devices, 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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K 973730

INTENDED USE FORM

Page 1 of 1

510 (k) Number (if known) K973730

ે જિલ્લાન Device Name: Silicone Elastomer Sheeting Durasil I and II

Indications For Use:

Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, 想: dural covering .005 inch, nasal septal repair, tendon anastomosis, neural repair - . 007 inch. correction of strabismus .010 inch, repair - . 020 inch, orbital floor repair . 040inch, galea hemodialysis shunt anchors .060. Reinforced - Facilitation of osteogenesis . 007inch, repair of urethral strictures . 007inch, staged repair of omphalocoel .020inch, repair of orbital floor fractures .040inch.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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Over-The-Counter-Use

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Division of Grievance Redressive Dave,
EAN Number: K973730

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.