(30 days)
Ethicon, Inc. Bone Wax, CP Medical, Inc. Bone Wax
Not Found
No
The 510(k) summary describes a simple mixture of waxes and does not mention any AI or ML components or capabilities.
No
The device is described as "bone wax" used for "control of bleeding from bone surface," which is a hemostatic agent, not a device that cures, treats, or prevents disease or affects the structure or function of the body in a therapeutic manner.
No
The device is described as a mixture used for controlling bleeding during surgical operations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "sterile mixture of beeswax, paraffin, and isopropyl palmitate," which are physical substances, 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 "for control of bleeding from bone surface during surgical operations." This describes a direct therapeutic action on the patient's body during surgery.
- Device Description: The device is a mixture of substances applied directly to the bone surface.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not involve the analysis of any biological specimens.
Therefore, the Sharpoint Lukens® bone wax is a surgical device used for hemostasis (controlling bleeding) during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sharpoint Lukens® Bone Wax for control of bleeding from the bone surface during surgical operations.
Product codes
MTJ
Device Description
The Sharpoint Lukens® Bone Wax is a sterile mixture of beeswax, paraffin, and isopropyl palmitate. It has a waxy ordor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical operations
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)
Ethicon, Inc. Bone Wax, CP Medical, Inc. Bone Wax
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K050292 page 1/3
MAR 9 - 2005
Image /page/0/Picture/2 description: The image shows the logo for Surgical Specialties Corporation. The logo features the company name in a stylized font, with the words "Surgical Specialties" stacked on top of "Corporation." To the right of the company name is a black triangle pointing to the right. Below the company name is the tagline "Incision & Healing Technologies" in a smaller font.
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | Surgical Specialties Corporation |
|---|---|
| Address: | 100 Dennis Drive |
| Reading, PA 19606 | |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth Lazaro |
| Regulatory Affairs Specialist | |
| Date Prepared: | February 1, 2005 |
| Name of Device: | Sharpoint Lukens® Bone Wax |
|---|---|
| Common / Usual | |
| Classification Name: | MTJ |
| Bone Wax |
| Predicate Devices: | Ethicon, Inc. Bone Wax
CP Medical, Inc. Bone Wax |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The Sharpoint Lukens® Bone Wax for control of
bleeding from the bone surface during surgical
operations. |
1
Image /page/1/Picture/0 description: The image shows the text 'K050292' and 'page 2/3' at the top. Below that is the logo for 'Surgical Specialties Corporation'. The logo is in a stylized font, with a black triangle pointing to the left.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
Device Description
The Sharpoint Lukens® Bone Wax is a sterile mixture of beeswax, paraffin, and isopropyl palmitate. It has a waxy ordor.
| Technological Characteristics: | Bone Wax is commonly used in medical applications to control bleeding. The characteristics are the same for the proposed Sharpoint Lukens® Bone Wax as the Ethicon's Bone wax as described in this submission. |
|---|---|
| -------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
2
K050292 Page 3/3
Image /page/2/Picture/1 description: The image shows the logo for Surgical Specialties Corporation. The logo is in black and white and features the company name in a stylized font. A black triangle is to the right of the company name. Below the company name is the word "CORPORATION" in a smaller font.
10
510(k) SUMMARY OF SAFETY AND EFFECTIV
Substantial Equivalence
The Sharpoint Lukens® Bone Wax is equivalent in the intended use to the predicate devices, Ethicon Bone Wax and CP Medical Bone Wax. The Done was arracteristics have been demonstrated to be equivalent. The components of Sharpoint Lukens® Bone Wax, Ethicon Bone Wax and CP Medical Bone wax are the same and raise no new issues of safety and efficacy.
Sharpoint Lukens® Bone Wax Surgical Specialties Corporation
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. The text is in all capital letters and is evenly spaced around the curve.
Public Health Service
MAR 9 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K050292
Trade/Device Name: Sharpoint Lukens® Bone Wax Regulatory Class: Unclassified Product Code: MTJ Dated: February 24, 2005 Received: February 25, 2005
Dear Ms. Lazaro:
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 reframerice 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 docs 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.
4
Page 2 - Ms. Elizabeth Lazaro
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 (240) 276-0115. 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/indcx.html.
Sincercly yours.
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
5
Indications for Use
510(k) Number (if known):
Device Name: Sharpoint Lukens® Bone Wax
Indications For Use:
Sharpoint Lukens® bone wax is indicated for use for control of bleeding from bone surface during surgical operations.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K050292