The PASSmed which includes the subject components, is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Device Description

The PASSmed Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

The purpose of this submission is to include the following components to PASSmed Spinal System:

Ø7.2 mm Sacral screw length 30 mm: extension of the range cleared in -K032094
Ø6.5 mm Sacral screws in lengths ranging from 30 mm to 60 mm: same . design as sacral screws cleared in K032094
. Ø6 mm pre bent rods in lengths ranging from 40 mm to 110 mm: same design as rods cleared in K032094 before bending
. Creation of a commercial reference for the nut of polyaxial pedicle screw cleared in K032094.
Crosslink systems in lengths ranging from 22 mm to 62 mm; the crosslink is a nuts, plate and clamps assembly, that hooks onto the rods to the assembled PASS Spinal System (K032094) to provide torsional stability to the construct.

AI/ML Overview

The provided text describes a Special 510(k) submission (K070276) for the PASSmed Spinal System, focusing on product range extension and additional components. This submission is for a medical device (spinal fixation system), not an AI or software-based device. Therefore, the typical acceptance criteria and study designs associated with AI performance evaluations (like sensitivity/specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this document.

The "acceptance criteria" for this type of medical device submission are primarily related to mechanical performance and substantial equivalence to a predicate device. The study described is a mechanical performance study.

Here's an analysis based on the provided text, structured to answer the questions as best as possible within the context of a mechanical device:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Mechanical)	Reported Device Performance
Components are mechanically sound (e.g., strength, durability).	"Tests performed on the additional components according to ASTM F1717 or ASTM F1798, indicate that the products are as mechanically sound as other PASSmed devices commercially available."
Substantial Equivalence to predicate device (K032094).	The FDA determined the device is "substantially equivalent" to legally marketed predicate devices.
Conformance to ASTM F136 (for titanium alloy).	All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of number of components tested. Mechanical testing typically involves a sufficient number of samples to ensure statistical validity, but the specific quantity is not reported in this summary.
Data Provenance: The tests were performed on "additional components" of the PASSmed Spinal System. The location of the testing is not specified, but the submitter is "MEDICREA® Technologies" based in La Rochelle, France. The tests were likely conducted in a laboratory setting. This is a prospective evaluation of the new components' mechanical properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. For mechanical performance studies, "ground truth" is established by adherence to recognized industry standards (like ASTM F1717 or ASTM F1798) and material specifications (ASTM F136). The "ground truth" is the objective mechanical properties as measured against these standards, not expert interpretation.

4. Adjudication Method for the Test Set

Not Applicable. Mechanical tests are objective and typically do not require adjudication by multiple human experts. The results are quantitative measurements interpreted against established standards.

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 is a mechanical device, not an AI or diagnostic software. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. As this is a mechanical medical device, there is no "algorithm" or standalone software performance to evaluate.

7. The Type of Ground Truth Used

Standardized Mechanical Test Results / Material Specifications: The "ground truth" relies on the objective measurements obtained from tests conforming to ASTM F1717 or ASTM F1798 for mechanical performance, and adherence to ASTM F136 for material composition.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence. The predicate device (K032094) serves as a baseline for comparison.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, this question is not applicable. The performance of the predicate device (K032094) was established through similar mechanical testing and regulatory clearance processes.

Summary

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K070276

Fage 1 of 2

MEDICREA

SPECIAL 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

FP 21 2007

1. GENERAL INFORMATION

Trade Name	PASSmed Spinal System
Common Name	✓ Posterior pedicle screw system✓ Hooks✓ Sacral plate
Classification Name	✓ Spondylolisthesis Spinal Fixation Device System per MNH888.3070✓ Spinal interlaminal Fixation Orthosis per KWP 888.3050✓ Pedicle Screw Spinal System per MNI 888.3070
Class	Class II
Product Code	MNH / MNI / KWP
CFR section	888.3070 / 888.3050
Device panel	Orthopedic
Legally marketed predicatedevices	PASSMed Spinal System (MEDICREA): K032094
Reason for special 510(k)	Product range extension and additional components
Submitter	MEDICREA® TechnologiesZ.I. Chef de Baie17000 La Rochelle, France
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199E-Mail: ortho.medix@sbcglobal.net

2. PREDICATE DEVICE DESCRIPTION

3. DESCRIPTION OF DEVICE MODIFICATION

The purpose of this submission is to include the following components to PASSmed Spinal System:

Ø7.2 mm Sacral screw length 30 mm: extension of the range cleared in -K032094
Ø6.5 mm Sacral screws in lengths ranging from 30 mm to 60 mm: same . design as sacral screws cleared in K032094
. Ø6 mm pre bent rods in lengths ranging from 40 mm to 110 mm: same design as rods cleared in K032094 before bending
. Creation of a commercial reference for the nut of polyaxial pedicle screw cleared in K032094.

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Image /page/1/Picture/1 description: The image shows a close-up of a word in a document. The word is "PUERTA", which is in all capital letters. The letters are bold and have a black fill with a white outline. The background is a light gray color.

Crosslink systems in lengths ranging from 22 mm to 62 mm; the crosslink is a nuts, plate and clamps assembly, that hooks onto the rods to the assembled PASS Spinal System (K032094) to provide torsional stability to the construct.

4. INTENDED USE

PERFORMANCE DATA 5.

When applicable, the tests performed on the additional components according to ASTM F1717 or ASTM F1798, indicate that the products are as mechanically sound as other PASSmed devices commercially available.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDICREA® Technologies % Mr. J. D. Webb 1001 Oakwood Blvd. Round Rock, TX 78681

SEP 2 1 2007

Re: K070276

Trade/Device Name: PASSmed Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: August 23, 2007 Received: August 27, 2007

Dear Mr. Webb:

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 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 regally

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Page 2 - Mr. J. D. Webb

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" (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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely yours,

Mark A. Milliken

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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page 14

INDICATIONS FOR USE

510(k) Number (if known): K0711276

Device Name: PASSmed Spinal System

PASSmed Spinal System

Indications for Use

The PASSmed is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

Mark A. McPherson

Neurological Devices
510(k) Number
K070276

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.