(30 days)
Not Found
No
The device description and intended uses are purely related to a physical silicone sheeting material for surgical applications. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is intended to treat or manage various medical conditions and facilitate physiological processes like neural regeneration and osteogenesis.
No
The AART Silicone Sheeting is described as a medical grade silicone elastomer intended for various surgical and non-surgical applications, such as wound dressing, nasal splinting, and reconstruction. Its purpose is to facilitate healing, protect tissues, or provide structural support, not to diagnose medical conditions or diseases.
No
The device description clearly states it is manufactured from a medical grade silicone elastomer and is a physical sheeting product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The AART Silicone Sheeting is described as a medical grade silicone elastomer intended for various surgical and non-surgical applications within the body or on the surface of the body (like wound dressing). Its intended uses involve physical placement and structural support, not the analysis of biological samples.
The device is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AART Silicone Sheeting has a variety of intended uses. The silicone sheeting is intended for short term and long term applications.
Short term indications for use:
- Nasal splinting
- Wound dressing
- Management of keloid or hypertrophic scarring
- Temporary use in TMJ disease .
- Temporary joint shims .
- Laboratory-uses
Long term indications for use:
- Nasal septal repair
- Orbital floor reconstruction
- Tympanic membrane repair
- Dialysis shunt anchoring
- Durameter repair
- Staged repair of omphalocoel .
- Lengthening of extraocular muscles
- As a protective sheathing to help facilitate neural regeneration and tendon anastomosis .
- As a protective sheathing to help facilitate osteogenesis .
- Other uses deemed appropriate by the using surgeon
Caution: The American Academy of Oral Maxillofacial Surgeons recommends against the use of silicone products for permanent treatment of Temporo Mandibular Joint Disease.
Product codes
MIB
Device Description
The AART Silicone Sheeting is manufactured from a medical grade silicone elastomer intended for long term implantation. The sheeting will be provided reinforced or non-reinforced in three sizes of varying thicknesses. The AART Silicone Sheeting is intended to be used for various surgical and non-surgical applications and may be trimmed by scalpel or scissors where additional shaping by the surgeon may be necessary.
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)
Reference Device(s)
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
022223
AUG 0 8 2002
ATTACHMENT 7
510(k) Summary
July 2, 2002
| Applicant: | Aesthetic and Reconstructive Technologies, Inc. (AART) |
|---|---|
| 3545 Airway Drive, Suite 108 | |
| Reno, NV 89511 | |
| (775) 853-6800 / FAX (775) 853-6805 | |
| Contact Person: | Catherine Riple |
| Consultant for AART, Inc. | |
| (805) 239-1059 | |
| Proprietary Name: | AART Silicone Sheeting |
| Common Name: | Silicone Carving Block |
| Classification Name: | Elastomer, Silicone Block |
Substantial Equivalence: The AART Silicone Sheeting is substantially equivalent in function, design, performance and materials to the Seare Biomedical Silicone Sheeting marketed by Seare Biomedical Corporation of Salt Lake City, Utah.
Device Description: The AART Silicone Sheeting is manufactured from a medical grade silicone elastomer intended for long term implantation. The sheeting will be provided reinforced or non-reinforced in three sizes of varying thicknesses. The AART Silicone Sheeting is intended to be used for various surgical and non-surgical applications and may be trimmed by scalpel or scissors where additional shaping by the surgeon may be necessary.
The intended use for the AART Silicone Sheeting is for various surgical and non-Intended Use: surgical applications. The silicone sheeting is intended for short term and long term applications.
Predicate Device: The AART Silicone Sheeting is substantially equivalent in material, design, function, and performance to the Seare Biomedical Silicone Sheeting marketed by Seare Biomedical Corporation of Salt Lake City, Utah. All products have virtually identical intended uses and are offered in similar sizes, thicknesses, and options of reinforcement or nonreinforcement.
Packaging: The AART Silicone Sheeting will be offered sterile. The sheeting will be packaged individually in a double Tyvek® pouch configuration. One size of sheeting will be offered both individually or in boxes of ten. Once steallized the individual sheeting will then be packaged in a protective plastic bag along with a package insert for inventory and shipping. Sheeting sold in boxes of ten will be boxed after sterilization along with a package insert.
Sterilization: The AART Silicone Sheeting is offered sterile. Sheeting will be sterilized by Gamma Radiation. The radiation dose level will be a minimum of 25kGy or as determined by the validation studies. The sterility assurance level (SAL) for the AART Silicone Sheeting will be 10 - .
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three overlapping profiles of human faces, creating a sense of depth and connection.
AUG 0 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesthetic and Reconstructive Technologies, Inc. c/o Catherine Riple 5871 Lone Pine Place Paso Robles, California 93446
Re: K022223
Trade/Device Name: AART Silicone Sheeting Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: MIB Dated: July 2, 2002 Received: July 9, 2002
Dear Ms. Riple:
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 mav 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.
2
Page 2 -- Ms. Catherine Ripple
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Stypt Elwrdn
LNSulie M. Witte, Ph.D., M.D.
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
3
ATTACHMENT 1
Page 1 of 1
510 (k) NUMBER (IF KNOWN): K022223.
DEVICE NAME:
AART Silicone Sheeting
INDICATIONS FOR USE:
The AART Silicone Sheeting has a variety of intended uses. The silicone sheeting is intended for short term and long term applications.
Short term indications for use:
- Nasal splinting ●
- Wound dressing ●
- Management of keloid or hypertrophic scarring �
- Temporary use in TMJ disease .
- Temporary joint shims .
- Laboratory-uses ●
Long term indications for use:
- Nasal septal repair ●
- Orbital floor reconstruction ●
- Tympanic membrane repair ●
- Dialysis shunt anchoring ●
- Durameter repair ●
- Staged repair of omphalocoel .
- Lengthening of extraocular muscles
- As a protective sheathing to help facilitate neural regeneration and tendon anastomosis .
- As a protective sheathing to help facilitate osteogenesis .
- Other uses deemed appropriate by the using surgeon ●
Caution: The American Academy of Oral Maxillofacial Surgeons recommends against the use of silicone products for permanent treatment of Temporo Mandibular Joint Disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Hyt Purdu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZZZZZ3 510(k) Number -