(170 days)
Not Found
No
The summary describes a mechanical barrier for controlling bone bleeding and contains no mention of AI or ML.
Yes
The device is used for the control of bleeding from bone surfaces, which suggests it is used to treat a medical condition or symptom, thus qualifying it as a therapeutic device.
No
The device, "Auto Suture* Bone Wax**," is indicated for the control of bleeding from bone surfaces by creating a mechanical barrier, which is a therapeutic function, not a diagnostic one.
No
The device description clearly indicates it is a physical substance ("mechanical barrier") used to control bleeding, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control bleeding from bone surfaces by creating a mechanical barrier. This is a direct interaction with the body (a surgical aid), not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description reinforces the mechanical barrier function, which is a physical action on tissue, not a diagnostic test.
- 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 or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, Auto Suture* Bone Wax** is a surgical device used to control bleeding, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Auto Suture* Bone Wax** is indicated for use in the control of bleeding from bone surfaces.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device Description
Auto Suture* Bone Wax** is designed to control bleeding from bone surfaces by the creation of a mechanical barrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces
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.
Ethicon™ Bone Wax (preamendment), Lukens™ Bone Wax (K791495)
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
N/A
0
| IX. | 510(k) Summary of Safety and Effectiveness | OCT 24 1997 |
|---|---|---|
| • SUBMITTER: | United States Surgical Corporation | |
| 150 Glover Avenue | ||
| Norwalk, CT 06856 | ||
| • CONTACT PERSON: | Melissa Mazzoni | |
| • DATE PREPARED: | May 5, 1997 | |
| • CLASSIFICATION NAME: | Unclassified | |
| • COMMON NAME: | Bone Wax | |
| • PROPRIETARY NAME: | Trademark name not yet determined | |
| • PREDICATE DEVICES: | Ethicon™ Bone Wax (preamendment) | |
| Lukens™ Bone Wax (K791495) | ||
| • DEVICE DESCRIPTION: | Auto Suture* Bone Wax** is designed to control | |
| bleeding from bone surfaces by the creation of a | ||
| mechanical barrier. | ||
| • INTENDED USE: | Auto Suture* Bone Wax** is indicated for use | |
| in control of bleeding from bone surfaces. | ||
| • MATERIALS: | All material components of Auto Suture* Bone | |
| Wax** have been evaluated for biocompatibility in | ||
| accordance with ISO Standard #10993-1. The | ||
| materials have been found to be safe for their | ||
| intended use. |
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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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 2 4 1997
Ms. Melissa Mazzoni Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re: K971680 Trade Name: Auto Suture* Bone Wax ** Regulatory Class: Unclassified Product Code: MTJ Dated: August 22, 1997 Received: August 26, 1997
Dear Ms. Mazzoni:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 - Ms. Melissa Mazzoni
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,
to coellato
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
3
IV. Indications For Use:
510(k) Number (if known): K97 1680
Auto Suture* Bone Wax** Device Name:
Indications For Use:
Auto Suture* Bone Wax** is indicated for use in the control of bleeding from bone surfaces.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X OR Over-The-Counter Use:_**_
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 1971680
Page
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