(170 days)
Not Found
No
The summary describes a bone wax composed of beeswax and paraffin, with no mention of AI or ML technology.
No
The device is indicated for controlling bleeding from bone surfaces, which is a supportive function during a medical procedure, not a therapeutic treatment itself for a disease or condition. Its purpose is mechanical hemostasis.
No
The device, CP Medical Bone Wax, is indicated for the control of bleeding from bone surfaces, which is a therapeutic function, not a diagnostic one. It is a beeswax and paraffin formulation used as a mechanical aid, not for detecting or identifying a disease or condition.
No
The device description explicitly states it is composed of a beeswax and paraffin formulation, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "control of bleeding from bone surfaces." This is a direct therapeutic intervention on the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a "beeswax and paraffin formulation." This is a physical material used to stop bleeding, not a reagent or instrument used for analyzing biological samples.
- 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
The device is clearly intended for surgical use to control bleeding during procedures involving bone.
N/A
Intended Use / Indications for Use
The CP Medical 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
The proposed device is composed of a beeswax and paraffin formulation.
The proposed device is manufactured in compliance with cGMP and ISO quality standards.
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)
This device is proven to be reasonably safe for use as an implantable mechanical aid.
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.
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
SAFETY AND EFFECTIVENESS SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with Volume 21 of the Code of Federal Regulations, this is to serve as a Summary of Safety and Effectiveness for the proposed CP Medical Bone Wax.
| Manufacturer: | CP Medical, Inc.
836 NE 24th Avenue
Portland, OR 97232
Phone: 503-232-1555
FAX: 503-230-9993 |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sue Ridge, Technical Writer - RA/QA |
| Device Name: | Trade or Proprietary Name: CP Medical Bone Wax
Common Name: Bone Wax
Classification: Unclassified |
| Date Prepared: | April 15, 2003 |
| Device Description: | The proposed device is composed of a beeswax and paraffin formulation.
The proposed device is manufactured in compliance with cGMP and ISO quality standards. |
| Predicate Devices: | The proposed device is substantially equivalent to other legally marketed bone waxes, including Ethicon Bone Wax (Preamendment, Ethicon, Inc.), Lukens Bone Wax (K791495, Lukens Medical Corporation), and Auto Suture® Bone Wax (K971680, United States Surgical). |
| Indications: | The CP Medical Bone Wax is indicated for use in the control of bleeding from bone surfaces. The device is supplied sterile and is SINGLE USE ONLY. The device may be supplied nonsterile on OEM basis only. |
| Intended Use: | The CP Medical Bone Wax is intended to be used in the control of bleeding from bone surfaces. |
| Summary of Clinical and Non-Clinical Studies: | This device is proven to be reasonably safe for use as an implantable mechanical aid. |
| Comparison of Technological Characteristics: | The proposed device, Bone Wax, is similar, if not identical, to the predicate device in composition. Manufacture of this device, including QC testing, is in substantial compliance with current QSR and ISO quality standards. |
- ୧୦ -
end
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, with three horizontal lines above them. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2003
Ms. Sue Ridge Regulatory Affairs Associate CP Medical, Inc. 836 NE 24th Avenue Portland, Oregon 97232
Re: K024372 Trade/Device Name: CP Medical Bone Wax Regulatory Class: Unclassified Product Code: MTJ Dated: April 15, 2003 Received: April 17, 2003
Dear Ms. Ridge:
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.
2
Page 2 - Ms. Sue Ridge
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. 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" (21CFR Part 807.97) you may obtain. 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 yours,
Muriam C. Provost
to 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
INDICATIONS FOR USE
| 510(k) (if known): | K024372 |
|---|---|
| DEVICE Name: | Bone Wax |
Indications for Use:
The CP Medical 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 _____________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Muriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K024372