The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.

The Posterior Lumbar System 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 spondylothesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Posterior Lumbar System is a pedicle screw system 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.

Device Description

As a special 510(k) submission, the predicate device to which we are claiming equivalence is our own product, Sintea Biotech's Posterior Lumbar System (K020085). This 510(k) submission represents a modification to the predicate, in which the locking cap threads are modified and additional size diameter screws are added to the already cleared Posterior Lumbar System.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Posterior Lumbar System Multi-Axial Screws - DESCO" by Sintea Biotech, Inc. It's a review by the FDA determining substantial equivalence to predicate devices, rather than a study proving acceptance criteria for a new AI/software device.

Therefore, the provided document does not contain any of the requested information regarding acceptance criteria or a study proving a device meets acceptance criteria for an AI/software product. The document pertains to a traditional medical device (pedicle screws) and its regulatory clearance process, where "substantial equivalence" is the key determination, not performance against specific acceptance criteria in the context of an AI study.

Specifically, there is no information on:

A table of acceptance criteria and reported device performance for an AI/software.
Sample sizes or data provenance for a test set.
Number of experts, their qualifications, or adjudication methods for ground truth.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
Standalone algorithm performance.
Type of ground truth used (e.g., pathology, outcomes data) in the context of an AI study.
Sample size for a training set.
How ground truth for a training set was established.

The document primarily focuses on the device's indications for use and its substantial equivalence to previously cleared devices (K020085 and K043355), with a modification to locking cap threads and the addition of new screw sizes. The "Performance Data" section explicitly states to "Please see 510(k) submission for the Sintea Biotech's Multi-Axial Screws System, K043355," indicating that any relevant performance testing would be documented in that predicate device's submission, and would likely involve mechanical or biocompatibility testing for a physical implant, not software performance.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sintea Biotech, Inc. % Ms. Danielle Wernikowski Regulatory Affairs 407 Lincoln Road, 10L Miami Beach, FL 33139

JUL 1 8 2008

Re: K081631

Trade/Device Name: Posterior Lumbar System Multi-Axial Screws - DESCO Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicle screw spinal system Regulatory Class: H Product Code: MNI, MNH, KWP Dated: May 19, 2008 Received: June 18, 2008

Dear Ms. Wernikowski:

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.

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Page 2 - Ms. Danielle Wernikowski

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. Yourmay 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 vours.

Mark M. Mulhern

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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Indications for Use

510(k) Number (if known): K081631

Device Name: Posterior Lumbar System Multi-Axial Screws - DESCO

Indications for Use:

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 OF NEEDED)

Oerlave Brien DFMM
Division Sign off

Division of General. Restorative. and Neurological Devices

510(k) Number K08163)

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Sintea Biotech Posterior Lumbar System Multi-Axial Screw - DESCO 510(k) Summary May 19, 2008

I. Company:	Sintea Bioteqch, Inc.
	407 Lincoln Rd. Suite 10L
	Miami Beach, FL 33139
	(305) 673-6226

II. Proprietary Trade Name:	Sintea Biotech Posterior Lumbar System Multi-Axial Screw - DESCO
Regulation Number:	888.3050, 888.3070

Regulation Name: Spinal Interlaminal Fixation Orthosis, Spondylolosthesis Spinal Fixation Device System, and Pedicle Screw Spinal System, Class II

Product Code: KWP, KWQ, MNI

III. Product Description

IV. Indications

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V. Device Description

Please see 510(k) submission for Sintea Biotech's Multi-Axial Scrows System, K043355.

VI. Performance Data

Please see 510(k) submission for the Sintea Biotech's Multi-Axial Screws System, K043355

VII. Substantial Equivalence

Sintea Biotech, Inc. believes that the additions to the Posterior Lumbar System Multi-Axial Screws are substantially equivalent to the Sintea Biotech's Multi-Axial Screws System (K043355) with respect to functional design, indications for use, and principles of operation, performance, and materials.

Regulation Number and Section

N/A