(82 days)
Ceretene" 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.
Ceretene" 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. Ceretene" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC). Ceretene™ Soluble Implant Material contains no other additives or colorants. Ceretene" Soluble Implant Material is formed in bars and sheets of various weights ranging from 0.5 to 5 grams each. Ceretene" Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
Acceptance Criteria and Study for Ceretene™ Soluble Implant Material (K103047)
The provided documentation, K103047, describes Ceremed, Inc.'s Ceretene™ Soluble Implant Material. This submission focuses on regulatory clearance via the 510(k) pathway, asserting substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results. Therefore, the information provided below is derived from the absence of certain elements in the 510(k) summary and the nature of this regulatory pathway.
The 510(k) submission for Ceretene™ Soluble Implant Material does not contain a specific study designed to prove the device meets acceptance criteria in the manner typically seen for novel or significantly modified devices. Instead, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the "acceptance criteria" are implicitly met by demonstrating that the new device has the same fundamental scientific technology, indications, intended use, and performance as equivalent predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" and quantifiable "reported device performance" from a dedicated clinical study are not provided in the document. The acceptance criteria are broadly focused on demonstrating equivalency in various aspects as outlined below:
| Acceptance Criteria Category | Description of Equivalency/Performance (Based on 510(k) Submission) |
|---|---|
| Indications for Use | * Acceptance: The indications for use for Ceretene™ Soluble Implant Material are substantially equivalent to those of the predicate device (Ceretene™ K081531 and Ostene®CT K091636). * Reported Performance (from submission): "Ceretene™ 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." This is presented as equivalent to the predicates without explicit comparative performance data. |
| Intended Use | * Acceptance: The intended use is substantially equivalent to the predicate devices. * Reported Performance (from submission): "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 has the same fundamental scientific technology as the legally marketed predicate Ceretene™ (K081531) and is substantially equivalent in indications, intended use, and performance..." (No further specific performance data on intended use provided for the new device beyond this statement). |
| Design | * Acceptance: The design is identical or substantially equivalent to the predicate devices. * Reported Performance (from submission): "is identical in design, materials, and sterilization to the predicate Ostene®CT (K091636)." "Ceretene™ Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC)." Specific design parameters (e.g., bar/sheet weights: 0.5 to 5 grams) are described, intending to show similarity to predicates without specific performance metrics against those parameters. |
| Materials | * Acceptance: The materials are identical or substantially equivalent to the predicate devices. * Reported Performance (from submission): "is identical in design, materials, and sterilization to the predicate Ostene®CT (K091636)." "Ceretene™ Soluble Implant Material contains no other additives or colorants." The core material (water-soluble alkylene oxide copolymers) is implicitly accepted as equivalent in biocompatibility and functional properties to the predicates, as no new material testing data is presented. |
| Sterilization | * Acceptance: The sterilization method and resulting sterility are identical or substantially equivalent to the predicate devices. * Reported Performance (from submission): "is identical in design, materials, and sterilization to the predicate Ostene®CT (K091636)." "Ceretene™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized." The presumption is that this method achieves a sterility assurance level (SAL) equivalent to that of the predicate, without specific SAL data for this particular device appearing in the provided text. |
| Fundamental Scientific Technology | * Acceptance: The device shares the same fundamental scientific technology as legally marketed predicates. * Reported Performance (from submission): "The comparison demonstrates that the device in this submission has the same fundamental scientific technology as the legally marketed predicate Ceretene™ (K081531) and is substantially equivalent in indications, intended use, and performance..." This is a foundational claim of the 510(k) submission. |
| Performance | * Acceptance: The device's overall performance (efficacy, safety, functionality) is substantially equivalent to predicate devices. * Reported Performance (from submission): "The comparison demonstrates that the device in this submission has the same fundamental scientific technology as the legally marketed predicate Ceretene™ (K081531) and is substantially equivalent in indications, intended use, and performance..." This is a general statement. The document does not describe a specific performance study with quantitative outcomes, sample sizes, or specific acceptance criteria for attributes like dissolution rate, space-occupying effectiveness, or biological response. The "performance" assessment is based on the equivalency argument rather than new primary data. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific test set or clinical study with human or animal subjects with a defined sample size for performance evaluation of the Ceretene™ Soluble Implant Material. The 510(k) submission relies on non-clinical evaluations to establish substantial equivalence. These non-clinical evaluations typically refer to bench testing, material characterization, and comparison to predicate device specifications, not a test set in the sense of a clinical trial. Therefore, there is no reported sample size or data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there is no clinical "test set" described in the document, there is no mention of experts used to establish ground truth. The substantial equivalence argument relies on regulatory and scientific review of the device's characteristics against predicate devices, which would involve internal experts at Ceremed and eventually FDA reviewers.
4. Adjudication Method for the Test Set
Since no clinical "test set" and no experts establishing ground truth are described, there is no adjudication method mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices involving human interpretation of images, which is not applicable to an implant material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable to the Ceretene™ Soluble Implant Material. This is a physical implant, not an algorithm or AI-driven diagnostic tool. Therefore, no standalone "algorithm only" performance study was conducted or is relevant.
7. Type of Ground Truth Used
Given the nature of the 510(k) submission, the "ground truth" for the Ceretene™ Soluble Implant Material is primarily based on demonstrated equivalence to legally marketed predicate devices. This involves:
- Predicate Device Performance and Safety: The established safety and effectiveness profile of the predicate devices (Ceretene™ K081531 and Ostene®CT K091636) serves as the "ground truth" for how a similar device should perform.
- Material Characterization: Ground truth for material properties (e.g., sterility, composition) is established through standard laboratory testing and adherence to recognized standards.
- Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 874.3620, general controls) forms part of the "ground truth."
There is no stated ground truth based on expert consensus, pathology, or outcomes data from a specific study of the new device in this document; rather, these would have informed the original clearance of the predicate devices.
8. Sample Size for the Training Set
This question is not applicable. The Ceretene™ Soluble Implant Material 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
This question is not applicable as there is no training set for this device.
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K103047 lofz
Ceremed, Inc.
Page 6 - 1
Traditional 510(k) - Ceretene" Soluble Implant Material
VI - 510 (K) SUMMARY
Submitted by:
(f
P
Tadeusz Wellisz, M.D. 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:
Tadeusz Wellisz, M.D.
September 24, 2010
Soluble Synthetic Polymer Implant Material
Ceretene™ Soluble Implant Material
21 CFR 874.3620
Ear, nose and throat synthetic polymer material
II
KHJ
Ceremed, Inc. Ceretene" (K081531) Ceremed, Inc. Ostene®CT (K091636)
Description of the device:
Ceretene" 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.
Ceretene" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC). Ceretene™ Soluble Implant Material contains no other additives or colorants. Ceretene" Soluble Implant Material is formed in bars and sheets of various weights ranging from 0.5 to 5 grams each.
JAN 5 20111
{1}------------------------------------------------
Ceremed, Inc.
Traditional 510(k) - Ceretene™ Soluble Implant Material
Ceretene" Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
Intended use:
7
Ceretene" 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 has the same fundamental scientific technology as the legally marketed predicate Ceretene" (K081531) and is substantially equivalent in indications, intended use, and performance; and is identical in design, materials, and sterilization to the predicate Ostene®CT (K091636).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
111 5 2011
Ceremed, Inc. % Tadeusz Wellisz, M.D. 3643 Lenawee Avenue Los Angeles, California 90016
Re: K103047
Trade/Device Name: Ceretene™ Soluble Implant Material Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Il Product Code: KHJ Dated: September 24, 2010 Received: October 15, 2010
Dear Dr. Wellisz:
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 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
. .
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Page 2 - Tadeusz Wellisz, M.D.
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 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.
lf you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please go to http://www.fda.gov/Aboutf-DA/CentersOffices/CDRH/CDRHOffices/ucm1 1 5800.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" (21)FOR Preci. 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 me (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
A. B. R.
for.
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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Ceremed, Inc.
Traditional 510(k) - Ceretene™ Soluble Implant Material
Y. INDICATIONS FOR USE:
510 (k) Number (if known):
Device Name: Ceretene™ Soluble Implant Material,
Indications For Use:
Ceretene" 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.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
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)
Daniel Krave for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103047
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.