(105 days)
Not Found
No
The summary describes a physical implant (a pin) made of stainless steel for repairing clavicle fractures. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are benchtop and cadaver testing, typical for a mechanical implant.
No.
The device is an implantable pin intended for mechanical repair of clavicle fractures, not for delivering therapy.
No
The device is described as an implant used to repair fractures, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description explicitly states it is an "implant made of 316 stainless steel," which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair an acute fracture, mal-union or non-union of the clavicle." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "implant made of 316 stainless steel." This is a physical object implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not do that.
This device is a surgical implant used for orthopedic repair.
N/A
Intended Use / Indications for Use
The ENSPLINTCMx™ Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Product codes
HSB
Device Description
The EnsplintCMxTM configuration consists of an implant made of 316 stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
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)
The results of the non-clinical (bench top and cadaver) laboratory testing demonstrate that the device is substantially equivalent. Clinical evaluation of the device is not required.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
OCT 1 0 2008
510(k) Summary
:
| Submitter's name | Sonoma Orthopedic Products, Inc. |
|---|---|
| Address | 650 Larkfield Center, Suite C |
| Santa Rosa, CA 95403 | |
| Phone Number | 707-526-1335 |
| Fax Number | 707-526-2022 |
| Name of contact person | Charles L. Nelson |
| Date summary was prepared | June 30, 2008 |
| Proprietary name/Trade name | EnsplintCMxTM GWG (gripper-wavy-gripper) |
| EnsplintCMxTM GGW (gripper-gripper-wavy) | |
| Common Name | Clavicle Pin |
| Classification Name | Intramedullary rod, 21 CFR 888.3020 |
| Pin, Fixation, Threaded 21 CFR 888.3040 | |
| Predicate Device | DePuy RockwoodTM Clavicle Pin |
| K991649, cleared July 14, 1999 | |
| Description of device | The EnsplintCMxTM configuration consists of |
| an implant made of 316 stainless steel. | |
| Intended use of device | The EnsplintCMxTM is intended to be used to |
| repair an acute fracture, mal-union, or non- | |
| union of the clavicle | |
| Comparison to Predicate Device | The EnsplintCMxTM has similar intended |
| use, performance characteristics, and | |
| materials to the predicate device. | |
| Performance Data (Non clinical) | The results of the non-clinical (bench top |
| and cadaver) laboratory testing demonstrate | |
| that the device is substantially equivalent. | |
| Clinical evaluation of the device is not | |
| required. |
Confidential Information
1
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 caduceus, a symbol often associated with medicine and healthcare, positioned to the right. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the edge of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2008
Sonoma Orthopedic Products, Inc. % Mr. Charles L. Nelson 650 Larkfield Center, Suite C Santa Rosa, CA 95403
Re: K081832
It on 6-2 Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 22, 2008 Received: September 22, 2008
Dear Mr. Nelson:
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 Forid, Or ug, 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, l'isting 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 - Mr. Charles L. Nelson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mulhausen
Mark N. Melkerson 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) Number (if known): K081832
Device Name: ENSPLINTCMx™ Clavicle Pin GWG (gripper-wavy-gripper)
Indications for Use:
INDICATIONS
The ENSPLINTCMx™ Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Prescription Use X (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)
Mark A. Milkeison
Page 1 of 1
Sign-Off) Division of General, Restorative, Enti Notrological Devices
Number K081832