(78 days)
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No
The 510(k) summary describes a surgical silo for ventral wall defect reduction and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for use in the treatment of omphalocele and gastroschisis, which are medical conditions, thus making it a therapeutic device.
No
This device is identified as a surgical product used in the treatment of ventral wall defects, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description "Ventral Wall Defect Reduction Silo" strongly suggests a physical, implantable device, not software. 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 use describes a surgical device used for the physical treatment of a medical condition (gastroschisis and omphalocele). IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description "Ventral Wall Defect Reduction Silo" also points to a physical device used in surgery, not a diagnostic test.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information based on laboratory tests.
- Mentioning reagents, calibrators, or controls.
Therefore, the Specialty Surgical Products Ventral Wall Defect Reduction Silo is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Specialty Surgical Products Ventral Wall Defect Reduction Silo is indicated for use in the treatment of I he opecially burgiour routed "remat" oschisis and ompalocele, where primary closure attempts must be abandoned in favor of a staged repair.
Product codes
FTL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
Mr. T. Jan Varner President & C.E.O. Specialty Surgical Products, Inc. 302 North First Street Hamilton, Montana 59840
Re: K973082 Trade Name: Ventral Wall Defect Reduction Silo Regulatory Class: II Product Code: FTL Dated: August 15, 1997 Received: August 18, 1997
Dear Mr. Varner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. T. Jan Varner
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
| Comments of the control of the control of the control of the control of the contribution of the contribution of the contribution of the contribution of the contribution of th |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Device Name: Ventral Wall Defect Reduction Silo
Indications For Use:
The Specialty Surgical Products Ventral Wall Defect Reduction Silo is indicated for use in the treatment of I he opecially burgiour routed "remat" oschisis and ompalocele, where primary closure attempts must be abandoned in favor of a staged repair.
(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 | 14973082 |
|---|---|
| --------------- | ---------- |
Prescription Use_ Company of the complete of the complete of the complete of the complete of the complete the complete of the complete the complete of the complete the complete the complete th (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)