(67 days)
No
The device description and intended use clearly describe a physical material (wax) used to stop bleeding, with no mention of software, data processing, or any AI/ML related terms.
Yes.
The device is used to control bleeding from bone surfaces, which suggests a therapeutic action.
No
The device description clearly states its purpose is to control bleeding from bone surfaces by physically plugging vascular openings, not to diagnose any condition.
No
The device is a physical, wax-like material intended for surgical use, 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 "for use in the control of bleeding from bone surfaces." This describes a direct therapeutic action on the body (stopping bleeding), not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical material (wax) that is applied directly to bone to create a physical barrier and plug vascular openings. This is a mechanical action, not a diagnostic process.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the device is a surgical hemostatic agent used to control bleeding during procedures, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.
Product codes
MTJ
Device Description
AOC Done Wage. It is best used immediately following removal from the package, and our of the packager over cased in stickiness by additional handling and manipulation, if so can be of ence wax is provided sterile by irradiation and must not be resterilized.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JUL 27 2004
Page - 1/2
Ceremed, Inc. KOYI363 AOC Bone Wax 510 (k) Submission
VII - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitted by:
Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (310) 815-2125 Fax: (310) 815-2130
Tadeusz Wellisz, M.D. Contact Person: May 19, 2004 Date Prepared Bone Wax Common/Usual Name: AOC Bone Wax Proprietary Name: Unclassified Classification Name: Predicate Devices 4. Ethicon, Inc. Ethicon Bone Wax
Description of the device:
Desertifican of this an odorless, opaque wax-like material designed to be utilized directly AOC Done Wage. It is best used immediately following removal from the package, and our of the packager over cased in stickiness by additional handling and manipulation, if so can be of ence wax is provided sterile by irradiation and must not be resterilized.
Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical Osed for over he edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Intended use:
AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.
1
Ceramed Inc. AOC Bone Wax 510 (k) Submission
Substantial equivalence:
AOC Bone Wax has the same intended use and indications for use as Ethicon Bone Wax (preamendment), Lukens Bone Wax (K791495), which are manufactured from bee's wax, and Auto Suture Bone Wax (K971680), which is manufactured from a sterile mixture of glycolide, caprolactone, mannitol and ß-tricalcium phosphate. AOC Bone Wax is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. AOC Bone Wax contains no other additives or colorants and it is provided as sterile sticks weighing 2.5 grams each. The biocompatibility of AOC Bone Wax is in accordance with the standards set forth in ISO-10993 Biological Testing of Medical and Dental Materials and Devices.
The mechanical properties of AOC Bone Wax are substantially equivalent to the corresponding properties of the predicate devices, and any minor differences raise no new issues of safety and efficacy.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
JUL 27 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Tadeusz Wellisz, M.D. President Ceremed, Inc. 3643 Lenawee Avenue Los Angeles, California 90016
Re: K041363 Trade/Device Name: AOC Bone Wax Regulatory Class: Unclassified Product Code: MTJ Dated: May 19, 2004 Received: May 21, 2004
Dear Dr. Wellisz:
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.
3
Page 2 - Tadeusz Wellisz, M.D.
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.
Miriam C. Provost
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
4
Ceremed, Inc. 510 (k) Premarket Notification - AOC Bone Wax
XII. INDICATIONS FOR USE:
510 (k) Number (if known): K041363
Device Name: AOC Bone Wax
Indications For Use: AOC Bone Wax is indicated for use in the control of bleeding from bone surfaces.
Prescription Use
X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Muriam C Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number_________________________________________________________________________________________________________________________________________________________________