(86 days)
The Daralastic Anatomical Nasal Implants are intended to be used to augment or reconstruct the nasal bridge and nasal profile for cosmetic or reconstructive surgery.
Duralastic Nasal implants are "L" shaped or straight with concave convex dorsal aspect which reached from the alar catilage to the radix. These silicone elastomer rubber implants are made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Nasal Implants will be provided sterile and nonsterile. Several biocompatible pigments are used to make the white and flesh tone versions of these implants.
The provided text describes a 510(k) premarket notification for Duralastic Nasal Implants, focusing on their substantial equivalence to previously cleared devices. It does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics, test methodologies, or statistical analyses. The document is primarily concerned with regulatory approval based on material equivalence and intended use.
Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided text.
Based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of performance metrics for the device’s clinical efficacy or safety, nor does it report specific device performance results from a study designed to meet such criteria.
The "physical properties" listed can be considered inherent characteristics of the material used, not performance criteria from a clinical study.
| Acceptance Criteria (Inferred from Material Properties) | Reported Device Performance (Material Properties) |
|---|---|
| Durometer | 30 Shore A |
| Elongation | 650% |
| Tensile Strength | 950 PSI |
| Tear Strength (Tear Die C) | 150 PSI |
| Specific Gravity | 1.12 |
| Modulus (at 200% Elongation) | 300 PSI |
| Surface | Smooth and Textured |
| Biocompatibility | Thoroughly tested (referenced in Applied Silicone's Master File MAF-562) |
| Mutagenicity | Thoroughly tested (referenced in Applied Silicone's Master File MAF-562) |
| Carcinogenicity | Thoroughly tested (referenced in Applied Silicone's Master File MAF-562) |
| Cytotoxicity | Thoroughly tested (referenced in Applied Silicone's Master File MAF-562); Pigments also tested for cytotoxicity |
| Sterility (Post-sterilization) | Achieved via gamma radiation (2.5 - 4.2 Megarads) per ANSI/AAMI/ISO 1137-1994 Method 1 Testing |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a regulatory submission based on substantial equivalence, not a clinical performance study with a test set of patient data. The biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity are mentioned as "thoroughly tested" material characterizations referenced in a Master File (MAF-562), but no sample sizes or data provenance for these tests are provided in this K971481 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information pertains to studies establishing clinical performance, which is not detailed in this regulatory submission.
4. Adjudication method for the test set
Not applicable. There is no described test set requiring adjudication in this document.
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 device is a silicone implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a silicone implant, not an algorithm.
7. The type of ground truth used
For the material properties (biocompatibility, etc.), the "ground truth" would be established through specific laboratory tests and assays designed to evaluate these characteristics, as per the standards referenced (e.g., those implicitly followed for MAF-562). For sterility, the ground truth is established through validation of the sterilization cycle according to ANSI/AAMI/ISO 1137-1994.
8. The sample size for the training set
Not applicable. This information is relevant for machine learning models, not for this type of medical device submission.
9. How the ground truth for the training set was established
Not applicable. This information is relevant for machine learning models, not for this type of medical device submission.
Summary of what the document focuses on:
The document primarily focuses on establishing Substantial Equivalence (SE) to a predicate device (Applied Biomedical nasal implants, previously cleared under K952705). This means that instead of conducting new clinical trials to prove safety and effectiveness, the manufacturer argues that their device is as safe and effective as a legally marketed device due to similar technology, materials, and intended use.
Key arguments for SE:
- Same molds and materials: The Duralastic nasal implants use the "very same molds and materials" as the Applied Biomedical nasal implants.
- Material Characterization: The silicone elastomer (LSR 30 Implant Grade) and pigments are supported by a Master File (MAF-562) which details their biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity tests.
- Intended Use: The intended use for augmentation and reconstruction of the nasal contour is consistent.
- Sterilization: The sterilization process (gamma radiation) is validated according to recognized standards (ANSI/AAMI/ISO 1137-1994).
In essence, the "proof" the device meets acceptance criteria is primarily through its similarity to a previously approved device and the established safety of its constituent materials and sterilization process, rather than a standalone clinical study detailed within this summary.
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K97/481
Allied Biomedical Corporation 3850 Ramada Drive Paso Robles, CA 93446
JUL 18 1997
TAB H
510 (k) SUMMARY
PRODUCT DESCRIPTION
Duralastic Nasal implants are "L" shaped or straight with concave convex dorsal aspect which reached from the alar catilage to the These silicone elastomer rubber implants are made from radix. specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has thoroughly tested for biocompatibility, mutagenicity, been carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Nasal Implants will be provided sterile and nonsterile. Several biocompatible pigments are used to make the white and flesh tone versions of these implants.
SUBSTANTIAL EQUIVALENCE
Under it original 510(k) K952705, Duralastic Nasal implants were found SE to the Applied Biomedical nasal implants. In fact the very same molds and materials are used to produce the Duralastic nasal implants in the sterile form, because these molds were sold to Allied and Allied has not chanqed raw material suppliers.
INTENDED USE
Duralastic Nasal implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
PHYSICAL AND CHEMICAL PROPERTIES
The Duralastic Nasal implants are manufactured from Applied ins - Barazable - Moua # 40029 which is a platinum cured dimethyl polysiloxane system. All chemical characterizations are found in Applied Masterfile MAF-562. Titanium Oxide and Iron Oxide piqments are added to these implants when ordered by the physician. These piqments are tested for cytotoxicity.
The physical properties are: Durometer 30 Shore A, Elongation 650%, Tensile Strength 950 PSI, tear strength Tear Die C 150 PSI, Specific Gravity 1.12, Modulus 300 PSI at 200% Elongation, Surface Smooth and Textured.
STERILIZATION CYCLE
Duralastic Nasal Implants are sterilized via gamma radiation cycles of 2.5 - 4.2 Meqarads. The validation of this cycle was designed
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510(k) Summary Continued
and performed by STI of Brea, California. Sterigenics Corporation is the contract gamma sterilizer. The validation used Method i Testing as defined in the ANSI/AAMI/ISO 1137-1994 "Sterilization of rebeing as activerts - 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gerald Hanson Regulatory Affairs Allied Biomedical Corporation 3850 Ramada Drive Paso Robles, California 93446
JUL 1 8 1997
Re: K971478
Trade Name: Duralastic Anatomical Chin Implants Product Code: FWP
K971479 Trade Name: Duralastic Anatomical Malar Implants Product Code: LZK
K971481 Trade Name: Duralastic Anatomical Nasal Implants Product Code: ESR
Regulatory Class: II Dated: April 15, 1997 Received: April 23, 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
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Page 2 - Mr. Gerald Hanson
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. 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 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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Number_K971481 うこと K
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revice Name Duralastic Anatomical Nasal Implants
ind.cations For Use
The Daralastic Anatomical Nasal Implants are intended to be used to augment or reconstruct the nasal bridge and nasal profile for osmetic or reconstructive surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Over-The Counter Use
(Optional Format 1-2-96)
Pres ription Use Per 21 CFR 801 109)
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.