(30 days)
Not Found
No
The device description and intended use are for a physical bone wax, and there is no mention of AI, ML, image processing, or data sets.
No.
The primary purpose of AOC Bone Wax is to control bleeding from bone surfaces by creating a physical barrier, which is a mechanical action, not a therapeutic one in the sense of treating a disease or condition with a biological or pharmacological effect.
No
AOC Bone Wax is described as a material used to control bleeding from bone surfaces by creating a physical barrier, not for diagnosing a condition.
No
The device description clearly states it is a "wax-like material" and a "physical barrier," indicating a tangible, non-software component.
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 surfaces to create a physical barrier. This is a mechanical action, not a diagnostic process.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information about a patient's health status through in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This bone wax does not fit that description.
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 Bone Wax is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by additional handling and manipulation, if so desired. AOC Bone 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 barrier along the 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.
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
Page 9 - 1
Ceremed, Inc. AOC Bone Wax Special 510 (k) Submission
MAR 2 4 2005 IX - 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
Contact Person: Date Prepared
Common/Usual Name:
Proprietary Name:
Classification Name:
Predicate Device:
Tadeusz Wellisz, M.D. March 21, 2005
Bone Wax
AOC Bone Wax Ostene™, Osteotene™ Ceretene™
Unclassified
Ceremed, Inc. AOC Bone Wax K041363
Description of the device:
AOC Bone Wax is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by additional handling and manipulation, if so desired. AOC Bone 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 barrier along the 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.
Substantial equivalence:
The modified AOC Bone Wax has the same intended use fundamental scientific technology as the legally marketed AOC Bone Wax.
1
Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, yet conveys the department's mission of promoting health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Tadeusz Wellisz, M.D. President Ceremed, Inc. 3643 Lenawee Avenue Los Angeles, California 90016
Re: K050440
K030440
Trade/Device Name: AOC™ Bone Wax, Ostene™, Osteotene™, Ceretene™ Regulatory Class: Unclassified Product Code: MTJ Dated: February 16, 2005 Received: February 22, 2005
Dear Dr. Wellisz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(t) premailer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Ior use stated in the encrosale) (o tegain) to tegains the Medical Device Amendments, or to commerce prior to May 20, 1978, are encordance with the provisions of the Federal Food. Daug. devices mat have been require approval of a premarket approval application (PMA). and Costlictic Act (71ct) that to not requent of the general controls provisions of the Act. The You may, merciole, market the do result of the more of annual registration. Insting of general controls provisions of the rice, 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 If your device is crassified (500 a0070) ins. Existing major regulations affecting your device can hay be subject to sublications, Title 21, Parts 800 to 898. In addition. FDA may be found in the Obecannents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act that 11.7A has made a acted regulations administered by other Federal agencies. You must or any i caetar statues and registements, including, but not limited to: registration and listing (21 Comply with an the Act 870cm mores) (); good manufacturing practice requirements as set CI IS Far 607), attoring (21 CFR Part 820); and if applicable the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Tadeusz Wellisz, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you we cognifinding of substantial equivalence of your device to a legally premarked 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 If you desire specific acreoliare at (240) 276-0115. Also, please note the regulation entitled. Contact the Oriece of Complained in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Shall other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octess http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stypt Rurchs
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ceremed, Inc. Special 510 (k) - AOC Bone Wax
YII. INDICATIONS FOR USE:
510 (k) Number (if known): K050440
Device Name: AOC™ Bone Wax, Ostene™, Osteotene™, Ceretene™
Indications For Use: AOC Bone Wax is indicated for use in the control of bleeding from bone surfaces.
CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
× OR Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)
Stept Rlurchu
K050440
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Division Sign-Off
510(k) Number_________________________________________________________________________________________________________________________________________________________________