BLUE SHARK by MERIDAN MEDICAL | FDA 510(k) Summary

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

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Meridian Medical Blue Shark device.

Based on the provided text, the Blue Shark device is an external fixation system, and the submission is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving effectiveness through acceptance criteria and independent studies in the way a PMA (Pre-market Approval) would.

Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this type of submission.

Here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated or provided in the given text for the Blue Shark device. In a 510(k) submission for a device like an external fixator, "acceptance criteria" are typically related to mechanical performance (e.g., strength, durability, fatigue resistance) as demonstrated by bench testing, and comparisons to predicate devices. However, the document only broadly states "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."

Without specific test results or specifications for either the Blue Shark or its predicates, it's impossible to create this table.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable/Not provided. The submission focuses on demonstrating "similar technological characteristics, similar design and materials" to predicate devices, rather than a clinical "test set" in the context of imaging or diagnostic device performance. For mechanical devices, testing is usually in-vitro bench testing. The specific number of devices tested is not detailed.
Data Provenance: Not applicable/Not provided in detail. The "study" here is a comparison of technological characteristics to predicate devices. There's no mention of a patient-derived data set (e.g., retrospective or prospective, country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This question pertains to studies where expert judgment is used to establish "ground truth" (e.g., for diagnostic accuracy). For a mechanical external fixator, ground truth is established through engineering principles, material science, and mechanical testing results, not expert interpretation of patient data.

4. Adjudication method for the test set

Not applicable. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical external fixation system, not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. See point 5.

7. The type of ground truth used

Implied Ground Truth (for substantial equivalence): The "ground truth" in a 510(k) for a mechanical device is often rooted in established engineering standards, biocompatibility testing, material properties specifications, and in-vitro mechanical testing data, all compared against the performance and characteristics of the legally marketed predicate devices. The submission asserts "similar technological characteristics, similar design and materials" to the predicates. The success of the predicate devices in the market serves as an indirect "ground truth" for safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device and submission type. This concept applies to machine learning or AI models.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary of Findings:

The provided text describes a 510(k) submission for the "Blue Shark" external fixation system. This type of submission aims to demonstrate substantial equivalence to predicate devices, primarily through comparison of technological characteristics, design, and materials, often supported by bench testing (though specific test details are not provided here). It does not include the elements typically found in clinical trials or performance studies for diagnostic devices, such as extensive clinical test sets, expert ground truth establishment, or AI performance metrics. Therefore, most of the questions are not applicable to the information contained in this 510(k) summary.

Summary

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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/PlateCombination, 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.

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K070016 page

Description of the device:

Intended use of the device:

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.

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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

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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

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4. Indications for Use StatementIndications 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 rigidstabilization of complex fractures of the pelvic girdle. This externalfixation 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

Regulation Number and Section

§ 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.