(55 days)
Not Found
Not Found
No
The description focuses on the material and physical characteristics of silicone implants for chest augmentation and reconstruction, with no mention of AI or ML capabilities.
No.
The device is used for augmentation and reconstruction, which are cosmetic or structural modifications, not for treating a disease or condition.
No
The device is described as an implant for augmenting or reconstructing the pectoralis, not for diagnosing a condition or disease.
No
The device description clearly states the device is a physical implant made of silicone elastomers, intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Seare Biomedical Pectoralis Implants are silicone implants intended for surgical implantation into the body to augment the chest or reconstruct the pectoralis muscle. This is an in vivo (within the living body) application, not an in vitro test.
The provided information describes a surgically implanted medical device, not a diagnostic test performed on bodily samples.
N/A
Intended Use / Indications for Use
Seare Biomedical Pectoralis Implants / silicone carving blocks are intended to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle).
Product codes (comma separated list FDA assigned to the subject device)
MIC
Device Description
Seare Biomedical Pectoralis implants are essentially large concave convex oval structures. They are exposed onally formulated silicone elastomers designed for implantation. They are provided in two (2) orientations for each of the specially formation and only in the milablity. Surface characterity will way ironton beeks on intended to smooth to varying degrees of lexturing and pornsity. Seare Biometical Pectoralis Implants / silicone carving block same intended to smood for augmenting the chest by placing the inplant in the submuseular space via a trans-axillary incision. The Career Ricer be used to reconstruct the pectoralis depression of Poland's Syndrone Congenitally Absent Pectoralis Muscle). The Seare Biomedical used to reconstition the pectoralis deplession of rolance congramilar - differing in length and proccion. The length of these implants varies from 11.5cm to 20cm. The height varies from 9cm to 18cm and the thickness at the apex varies 1cm to 3.5cm. The Seare Biomedical Pectoralis Implants will be provided sterile and nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest, pectoralis
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)
Clinical Tests: None
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
982762
Image /page/0/Picture/1 description: The image shows a dark circular shape with many light-colored, curved lines scattered throughout. The lines appear randomly oriented and do not form any discernible pattern. The background of the circle is a uniform dark color, providing contrast to the lighter lines.
SEP 30 K
SEARE BIOMEDICAL CORPORATION
510(k) Summary
| Contact Information: | Seare Biomedical Corporation |
|---|---|
| 3190 Chula Vista Circle | |
| Salt Lake City, Utah 84121 | |
| Telephone: 1(801) 355-5533 | |
| Facsimile: 1(801) 942-1999 | |
| Trade Name: | Seare Biomedical Pectoralis Implants |
| Common Name: | Silicone Elastomer Pectoralis Implants |
| Classification Name: | Implant, Muscle, Pectoralis |
Substantial Equivalence: The Seare Riomedical Pectoralis Implant configurations are substantially equivalent in material, function, performance, and design to the Allied Biomedical Pectoralis Implans manufactured and marketed by Allied Biomedical and Hanson Medical Inc. (.
Device Description: Searc Biomedical Pectoralis implants are essentially large conceve conver on interestion. They are exponied Device Description: Seare Bromsonally formulated silicone elastomers designed for implantation. They are novided in two (2) orientations for cach of the specially formation and only in the milablity. Surface characterity will way ironton beeks on intended to smooth to varying degrees of lexturing and pornsity. Seare Biometical Pectoralis Implants / silicone carving block same intended to smood for augmenting the chest by placing the inplant in the submuseular space via a trans-axillary incision. The Career Ricer be used to reconstruct the pectoralis depression of Poland's Syndrone Congenitally Absent Pectoralis Muscle). The Seare Biomedical used to reconstition the pectoralis deplession of rolance congramilar - differing in length and proccion. The length of these implants varies from 11.5cm to 20cm. The height varies from 9cm to 18cm and the thickness at the apex varies 1cm to 3.5cm. The Seare Biomedical Pectoralis Implants will be provided sterile and nonsterile.
Indications For Use: Seare Biomecical Pectoralis Inplants / silicone carving blocks are intended to be used for augmenting the thurchuuts For Ose. Seale Diomeanen recolar space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Poctoralis Muscle).
Predicate Devices: The Seare Biomedical Pectoralis Implant configurations are substantially equivalent in Material, Innstion, performance, and design to the Allied Biomedical Pectoralis Implants manufactured and marketed by Allied Biomedical and Hanson Medical Inc. The products have identical indications for use and are offered in the same sizes and options.
Clinical Tests: None
Adverse S&E Information: None
William J. Seare, Jr. M.D.
William J. Seare, Jr. M.D.
President & C.E.O.
8/4/28
Date
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
William J. Seare, M.D. President & C.E.O. Seare Biomedical Corporation 3190 Chula Vista Circle Salt Lake City, Utah 84121
JAN 1 0 2017
Re: K982762
Trade/Device Name: Seare Biomedical Pectoralis Implants Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: MIC Dated: August 4, 1998 Received: August 6, 1998
Dear Mr. Seare:
This letter corrects our substantially equivalent letter of September 30, 1998.
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 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of
2
Page 2 - William J. Seare, M.D.
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 Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Also, please note http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Reportal?roblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
3
510(k) Number (if known):_K 88 2762
Device Name: Seare Biomedical Pectoralis Implants
Indications For Use:
Seare Biomedical Pectoralis Implants / silicone carving blocks are intended to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K982762 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)