(133 days)
Adaptain™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
Adaptain™ Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Adaptain" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain" "Soluble Implant Material contains no other additives or colorants. Adaptain"" Soluble Implant Material is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
This document describes the 510(k) submission for the Adaptain™ Soluble Implant Material, an ear, nose, and throat synthetic polymer material. The submission aims to demonstrate substantial equivalence to a predicate device, the Ceretene™ Soluble Implant Material (K081531).
Based on the provided text, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not detailed in a quantitative, performance-based manner that would typically be seen for a diagnostic or AI-driven device. Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The core "acceptance" is based on substantial equivalence, which implies the new device performs similarly to the predicate in all relevant aspects.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated by comparison to predicate) |
|---|---|
| Indications for Use | Identical to predicate device |
| Intended Use | Identical to predicate device |
| Design | Identical to predicate device |
| Materials | Identical to predicate device (comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend™), no other additives or colorants) |
| Sterilization | Identical to predicate device (provided sterile by irradiation) |
| Performance | Identical to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a "test set" or a specific study involving patient data (clinical or otherwise) with a defined sample size for performance evaluation. The substantial equivalence argument is based on comparing device characteristics rather than clinical outcomes. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as there is no "test set" and no "ground truth" establishment in the context of device performance in a clinical setting mentioned. The evaluation is based on a comparison of the device's characteristics to its predicate.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" for which adjudication would be required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of the device itself, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone "algorithm only" performance study was not done. The device is a physical implant material, not a software algorithm.
7. The Type of Ground Truth Used
This information is not applicable. The "ground truth" in this context is the established characteristics and performance of the predicate device, against which the new device is compared for "identicality." It's not a clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above – no training set for an AI/ML model.
Summary of the document's approach to "acceptance criteria" and "study":
The acceptance criteria for the Adaptain™ Soluble Implant Material appear to be qualitative: to be "identical in design, materials, indications, performance and sterilization" to its predicate, Ceretene™ Soluble Implant Material (K081531). The "study" proving this is a non-clinical evaluation that directly compares these aspects between the new device and the predicate. The FDA's 510(k) clearance signifies agreement that this comparison demonstrates substantial equivalence, allowing the new device to be marketed. This is a common pathway for medical devices that are similar to already legally marketed devices.
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JUN - 6 2012
20220
(Revised 06/05/12) 10F2 Ceremed, Inc. Traditional 510(k) - Adaptain™ Soluble Implant Material
VI - 510 (K) SUMMARY
Submitted by:
Chelsea Mitchell Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (310) 815-2125 Fax: (310) 815-2130
Contact Person:
Date Prepared
Common/Usual Name:
Proprietary Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Predicate Device:
Chelsea Mitchell
May 29, 2012 .
Soluble Synthetic Polymer Implant Material
Adaptain™ Soluble Implant Material
21 CFR 874.3620
Ear, nose and throat synthetic polymer material
II
KHJ
Ceremed, Inc. Ceretene ™ Soluble Implant Material (K081531)
Description of the device:
Adaptain™ Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.
Adaptain" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain" "Soluble Implant Material
contains no other additives or colorants. Adaptain"" Soluble Implant Material is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each.
Adaptain™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
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(Revised 06/05/12)
Traditional 510(k) – Adaptain" Soluble Implant Material
Indications for use:
Adaptain™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
Substantial equivalence:
The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this submission is identical in design, materials, indications, performance and sterilization to the predicate Ceretene " Soluble Implant Material (K081531).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and two curved lines representing legs or talons.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 6 2012
Ceremed, Inc % Ms. Chelsea Mitchell Vice President, Regulatory Affairs 3643 Lena Wee Avenue Los Angeles, California 90016
Re: K120220
Trade/Device Name: Adaption™ Soluble Implant Material Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: May 29, 2012 Received: May 31, 2012
Dear Ms. Chelsea Mitchell:
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
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Page 2 - Ms. Mitchell
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 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/ReportaProblem/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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ·
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(Revised 06/05/12) Ceremed, Inc. Traditional 510(k) - Adaptain™ Soluble Implant Material
V. INDICATIONS FOR USE:
510 (k) Number (if known):
Device Name: Adaptain™ Soluble Implant Material
Indications For Use:
Adaptain™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
OR
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Daire King lu MM
(Division Sign-Off)
Division of Surgical, Orthopedie, and Restorative Devices
510(k) Number K120220
Division Sign-Off
510(k) Number
§ 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.