(80 days)
Not Found
Not Found
No
The summary describes a passive material (sheeting) used for various surgical repairs and splinting. There is no mention of any computational or analytical functions, let alone AI/ML.
Yes
The device is indicated for repairing various anatomical structures and facilitating osteogenesis, which are therapeutic actions.
No
Explanation: The device is indicated for various repairs and coverings within the body, which are therapeutic actions rather than diagnostic procedures.
No
The intended use and anatomical sites described strongly suggest a physical material or implantable device, not a software-only product. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures and tissue repair within the body (in vivo). IVDs are used to examine specimens taken from the body (in vitro) to provide information about a person's health.
- Device Description: While the description is "Not Found," the intended uses clearly point to a device used directly on or within a patient.
- No mention of laboratory testing: There is no indication that this device is used in a laboratory setting to analyze samples.
Therefore, this device falls under the category of a medical device used for surgical and therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Sheeting is indicated for short term use for nasal splinting, wound dressings, scar coverings and temporary joint spacers.
For long term use, this device is indicated for tympanic membrane repair, dural covering, nasal septal repair, tendon anastamosis and neural repair, correction of strabismus, galea repair, orbital floor repair, hemodialysis shunt anchors, facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel and repair of orbital floor fractures.
Product codes
MIB
Device Description
Medisil Silicon Sheeting
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, wound, scar, joint, tympanic membrane, dural, nasal septal, tendon, neural, strabismus, galea, orbital floor, hemodialysis shunt, urethral, omphalocoel
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 1 2004
Mr. Alastair Winn Medisil Corporation 1735 N. Olive Street Ventura, California 93001
Re: K040042
Trade/Device Name: Medisil Silicon Sheeting Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose and throat synthetic polymer material Regulatory Class: II Product Code: MIB Dated: January 6, 2004 Received: January 12, 2004
Dear Mr. Winn:
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 such 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); 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.
1
Page 2 - Mr. Alastair Winn
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
60
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number K040042
March 25, 2004 (Revised from March 4, 2004 Version) (Revised from March 15 Version) (Revised from March 17 Version)
Device Name: Medisil Silicone Sheeting
Indications For Use:
Sheeting is indicated for short term use for nasal splinting, wound dressings, scar coverings and temporary joint spacers.
For long term use, this device is indicated for tympanic membrane repair, dural covering, nasal septal repair, tendon anastamosis and neural repair, correction of strabismus, galea repair, orbital floor repair, hemodialysis shunt anchors, facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel and repair of orbital floor fractures.
Prescription Use- Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use- No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________