ISOLA POLYAXIAL WASHER by DEPUY ACROMED

The ISOLA Spinal System is a pedicle screw systems 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 (pseudarthrosis).

The ISOLA Spinal System is also indicated for pedicle screw fixation 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.

The ISOLA Spinal System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

Device Description

The ISOLA Polyaxial Washer construct will allow the current monoaxial screws of the ISOLA Spinal System to exhibit properties similar to those of polyaxial screws.

AI/ML Overview

The provided document, K013441, is a 510(k) summary for the ISOLA Polyaxial Washer, a component of the ISOLA Spinal System. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria.

The document primarily describes the device, its intended use, and materials, and mentions that "Performance data were submitted to characterize the ISOLA Polyaxial Washer." However, it does not include:

A table of acceptance criteria and reported device performance values.
Details of a standalone algorithm performance study.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
Data provenance for a test set (country of origin, retrospective/prospective).
Number and qualifications of experts for ground truth establishment.
Adjudication methods.
The type of ground truth used (e.g., pathology, outcomes data).
The sample size for a training set.
How ground truth for a training set was established.

This is typical for 510(k) submissions for spinal fixation devices, which often rely on mechanical testing rather than AI-driven clinical performance studies.

Therefore, based solely on the provided text, I cannot extract the information required to populate the table or answer the specific questions about acceptance criteria and study details as they pertain to AI or diagnostic performance.

The "Performance Data" mentioned likely refers to mechanical testing (e.g., fatigue, static strength, torsion) to ensure the device meets engineering specifications and functions as intended, rather than clinical efficacy or diagnostic accuracy as would be relevant for an AI/diagnostic device.

To answer your request, if this were a device requiring clinical performance or AI evaluation (which it is not), the information would typically be presented in a much more detailed clinical study report section, which isn't present in this 510(k) summary.

Summary

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K013441
1042

IX. 510(k) Summary

NOV 1 6 2001

SUBMITTER: DePuy AcroMed, Inc. 325 Paramount Drive Raynham, MA 02780

CONTACT PERSON: Lisa A. Gilman

August 10, 2001 DATE PREPARED:

CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation

PROPRIETARY NAME: ISOLA Polyaxial Washer

MONARCH Spine System Polyaxial Washer PREDICATE DEVICES: (K010576)

DEVICE DESCRIPTION: The ISOLA Polyaxial Washer construct will allow the current monoaxial screws of the ISOLA Spinal System to exhibit properties similar to those of polyaxial screws.
INTENDED USE: The ISOLA Spinal System is a pedicle screw systems 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 (pseudarthrosis).

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Image /page/1/Picture/1 description: The image shows a handwritten text that appears to be a label or identifier. The text includes the alphanumeric string "K01344" stacked on top of "2OF2". The handwriting is in black ink and has a casual, slightly tilted style.

MATERIALS:

PERFORMANCE DATA:

Performance data were submitted to characterize the

Manufactured from ASTM F-138 implant grade

stainless steel.

ISOLA Polyaxial Washer.

DePuy AcroMed, Inc. Special 510K

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K013441 Trade/Device Name: ISOLA Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: October 16, 2001 Received: October 17, 2001

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Frank Maas

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Mark N Mulkern

Celia M. Witten, Ph.D., M.D. 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 III.

510(k) Number (if known): KO 1344 /

NOV 1 6 2001

ISOLA Polyaxial Washer Device Name:

Indications For Use:

The ISOLA Spinal 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:		OR Over-The-Counter
Use: (Per 21 CFR 801.109)

(Division Sign-Off)
Division of General, Restorative and Neurological Devices

DePuy AcroMed, Inc.Special 510K	Page 4
510(k) Number	K013441

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.