(89 days)
Not Found
No
The summary describes a purely mechanical external fixation device with no mention of software, image processing, AI, or ML.
No
The device is an external fixation device used for rigid stabilization of fractures, which falls under the category of orthopedic surgical devices rather than therapeutic devices that treat a disease or condition through non-surgical means. It provides physical support and stabilization rather than delivering therapy.
No
The device description indicates it is an external fixation device used for rigid stabilization of fractures, not for diagnosing them.
No
The device description explicitly states it is composed of physical elements like screws, rings, and a frame, which are hardware components.
Based on the provided information, the Blue Shark device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "rigid stabilization of complex fractures of the pelvic girdle." This describes a surgical device used to treat a physical condition within the body.
- Device Description: The description details a physical device composed of screws, rings, and a frame that is implanted into the pelvis. This is consistent with a surgical implant/external fixation device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the Blue Shark is an external fixation device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blue Shark is an external fixation device indicated for the rigid stabilization of complex fractures of the pelvic girdle. This external fixation device can be utilized for Type B and Type C fractures.
Product codes
KTT
Device Description
The pelvic external fixators are composed of four different elements composing the frame of the fixator connected by screws and rings. The fixator is assembled on four steel screws that are implanted into the pelvis on the iliac crest depending on the selected implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic girdle
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K070016 page 172
5. 510(k) Summary
MERIDIAN MEDICAL
APR - 2 2007
1303 Avocado Avenue, Suite 265 Newport Beach, C.A. 92660
Submitter's name: Address:
Phone:
Fax number:
Meridian Medical 1303 Avocado Ave., Suite 265 Newport Beach, CA 92660 949-718-9220 949-718-9234
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821 grace@regulatoryspecialists.com
Date the summary was prepared: December 29, 2006
| Name of the device: | Blue Shark |
|---|---|
| Trade or proprietary name: | Blue Shark |
| Common or usual name: | External fixation system |
| Classification name: | Appliance, Fixation, Nail/Blade/Plate |
| Combination, Multiple Component (per 21 CFR section 888.3030) |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
| K# | Device Name | Applicant |
|---|---|---|
| K032427 | FEP | Meridian Medical |
| K011697 | EBI XFIX ACCESS PELVIC FIXATOR | EBI, L.P. |
1
K070016 page
Description of the device:
The pelvic external fixators are composed of four different elements composing the frame of the fixator connected by screws and rings. The fixator is assembled on four steel screws that are implanted into the pelvis on the iliac crest depending on the selected implantation.
Intended use of the device:
The Blue Shark is an external fixation device indicated for the rigid stabilization of complex fractures of the pelvic girdle. This external fixation device can be utilized for Type B and Type C fractures.
Summary of the technological characteristics of our device compared to the predicate device:
It has been shown that the Meridian Medical Blue Shark and the Predicates, FEP and EBI XFIX ACCESS PELVIC FIXATOR devices have similar technological characteristics, similar design and materials and are equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Meridian Medical % Ms. Grace Holland Regulatory Specialists, Inc. 3722 Sausalito Avenue Irvine, California 92606
APR - 2 2007
Re: K070016
Trade/Device Name: Blue Shark Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: December 29, 2006 Received: January 3, 2007
Dear Ms. Holland:
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
3
Page 2 - Ms. Grace Holland
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. 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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark A. Melleusen
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
·
| 4. Indications for Use Statement
| Indications for Use | |
|---|---|
| 510(k) Number (if known): | K070016 |
| Device Name: | Blue Shark |
| Indications for Use: | |
| The Blue Shark is an external fixation device indicated for the rigid | |
| stabilization of complex fractures of the pelvic girdle. This external | |
| fixation device can be utilized for Type B and Type C fractures | |
| 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 OF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| Page | 1 of 1 |
| 510(k) Number | K070016 |
| Regulatory Specialists, Inc. | Page 10 |
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