(97 days)
Not Found
No
The device description and performance studies focus on the material properties and equivalence to a predicate device, with no mention of AI or ML.
No
The device is indicated as a water-soluble implant material and space-occupying material to support the natural healing process, rather than actively treating a disease or condition.
No
Adaptain FastWrap™ is described as an implant material and a space-occupying material to aid in the healing process, not a device used to identify or analyze a medical condition.
No
The device description clearly states it is a physical, wax-like material and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a water-soluble implant and space-occupying material during the natural healing process. This describes a device used in vivo (within the body) to support healing, not a device used in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical material (wax-like bars/sheets) comprised of a sterile mixture of polymers, intended for direct application. This aligns with an implantable or space-occupying material, not a diagnostic reagent or instrument used to test biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
Therefore, Adaptain FastWrap™ is a medical device intended for surgical or therapeutic use, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Adaptain FastWrap™ 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.
Product codes (comma separated list FDA assigned to the subject device)
KHI
Device Description
Adaptain FastWrap™ 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 FastWrap "" is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain FastWrap " contains no other additives or colorants. Adaptain FastWrap™ is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each.
Adaptain FastWrap is provided sterile by irradiation and must not be resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Ceremed, Inc. Traditional 510(k) - Adaptain FastWrap™, Envelock™
Page 6 - 1 17 256 | lof Z
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
August 20, 2012
Soluble Synthetic Polymer Implant Material
Adaptain FastWrap™, Envelock™
21 CFR 874.3620
Ear, nose and throat synthetic polymer material
II
KHI
Ceremed, Inc. Ceretene " Soluble Implant Material (K120220)
Description of the device:
Adaptain FastWrap™ 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 FastWrap "" is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain FastWrap " contains no other additives or colorants. Adaptain FastWrap™ is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each.
Adaptain FastWrap is provided sterile by irradiation and must not be resterilized.
NOV 2 7 2012
1
4122561
zofz
Page 6 - 2
Ceremed, Inc. Traditional 510(k) - Adaptain FastWrap™, Envelock™
Intended use:
Adaptain FastWrap™ 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 Adaptain " Soluble Implant Material (K120220).
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ceremed, Incorporated % Ms. Chelsea Mitchell Vice President, Regulatory Affairs 3643 Lenawee Avenue Los Angeles, California 90016
November 27, 2012
Re: K122561
Trade/Device Name: Adaptain FastWrap™, Envelock™ Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: October 18, 2012 Received: October 19, 2012
Dear Ms. 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.
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 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
3
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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ceremed, Inc. Traditional 510(k) -- Adaptain FastWrap™, Envelock™
V. INDICATIONS FOR USE:
510 (k) Number (if known): K122561
Device Name: Adaptain FastWrap ", Envelock""
Indications For Use:
Indications For Use:
Adaptain FastWrap™ is indicated for use as a water-soluble implant material and as a
water-soluble space occupying material as an adjunct during the natu 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)
David Krause
(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K122561
Division Sign-Off
510(k) Number_