The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

Device Description

The DePuy PULSE Lumbar Cage System is designed for use as a lumbar intervertebral body fusion device. The implant devices are available in various geometries and sizes to accommodate patient anatomy. The implant devices are manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 and tantalum markers per ASTM F-560.

AI/ML Overview

Here is an analysis of the provided 510(k) summary regarding the DePuy PULSE™ Lumbar Cage System, focusing on the acceptance criteria and the study proving its compliance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Type)	Standard	Reported Device Performance
Static Axial Compression Testing	ASTM F-2077	"The acceptance criteria was/were met."
Dynamic Axial Compression Testing	ASTM F-2077	"The acceptance criteria was/were met."
Static Compression Shear Testing	ASTM F-2077	"The acceptance criteria was/were met."
Dynamic Compression Shear Testing	ASTM F-2077	"The acceptance criteria was/were met."
Subsidence Testing (Static Axial Compression)	ASTM F-2267	"The acceptance criteria was/were met."

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of non-clinical mechanical tests. These tests evaluated the physical performance of the DePuy PULSE™ Lumbar Cage System against established ASTM standards for intervertebral body fusion devices.

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

Sample Size: The 510(k) summary does not specify the exact sample size (number of devices tested) for each mechanical test. It only states that the tests were conducted.
Data Provenance: The data provenance is from non-clinical laboratory testing. This type of test data is generally generated internally by the manufacturer or a contracted lab. The document does not provide details on the country of origin of the data, but it is implied to be from Medos International Sàrl's testing or a lab they utilized. These would be prospective tests, specifically designed to evaluate the product.

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

Not Applicable. For non-clinical mechanical testing, "ground truth" as it's typically understood in clinical or AI studies (e.g., expert consensus on images or pathology results) is not relevant. The "ground truth" is defined by the acceptance criteria established in the ASTM standards (ASTM F-2077 and ASTM F-2267) and the measured physical properties of the device. Evaluation against these standards is performed by engineers or technicians, not clinical experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, this is non-clinical mechanical testing. There is no adjudication method in the context of clinical expert review. The results are objectively measured and compared against the defined acceptance criteria of the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed. The 510(k) summary explicitly states, "No clinical tests were performed." MRMC studies are clinical studies involving human readers, which were not conducted for this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical intervertebral cage system, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on pre-defined mechanical performance criteria established in the referenced ASTM standards (ASTM F-2077 and ASTM F-2267). These standards specify the methods for testing and the performance characteristics (e.g., resistance to static/dynamic compression, shear, and subsidence) that the device must meet.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of this 510(k) submission.

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

Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply.

Summary

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510(K) SUMMARY

Submitter:	Medos International SàrlChemin-Blanc 38Le Locle, CH-NE 2400, Switzerland
Contact Person:	Eugene BangRegulatory Affairs AssociateDePuy Spine, Inc.Voice: (508) 977-3966Fax: (508) 828-3797
Date Prepared:	March 29, 2012
Trade Name:	DePuy PULSE™ Lumbar Cage System
Device Class:	Class II
Product Code(s):	MAX
Common Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Classification Name:	Intervertebral Body Fusion Device
Regulation Number:	888.3080
Predicate Devices:	Concorde System - K081917, K103488Concorde Curve System - K101923Concorde Inline System - K110694Genesys Spine Interbody Fusion System - K103034RAY Threaded Fusion Cage - P950019
Device Description:	The DePuy PULSE Lumbar Cage System is designed for use as alumbar intervertebral body fusion device. The implant devices areavailable in various geometries and sizes to accommodate patientanatomy. The implant devices are manufactured from medical gradepolyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 andtantalum markers per ASTM F-560.
Indications:	The DePuy PULSE Lumbar Cage System is indicated for use as intervertebralbody fusion devices in skeletally mature patients with degenerative disc disease(defined as discogenic back pain with degeneration of the disc confirmed bypatient history and radiographic studies) at one or two contiguous levels of thelumbar spine (L2-S1). Patients should have six months of non-operativetreatment prior to surgery. These implants are used to facilitate fusion in thelumbar spine and are placed via a PLIF or TLIF approach using autogenous bone.When used as intervertebral body fusion devices these implants are intended foruse with DePuy Spine supplemental internal fixation products.
Materials:	Manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LT1)per ASTMF F-2026 and tantalum markers per ASTM F-560.
Comparison toPredicate Device:	The substantial equivalence of the subject device to the predicates indentifiedabove is based upon the equivalence of intended use, design (fundamentalscientific technology), materials, manufacturing methods, performance, sterility,biocompatibility, safety and packaging design.
Non-clinical TestSummary:	The following mechanical tests were conducted:
	• Static and dynamic axial compression testing in accordance with ASTM F-2077 Standard Test Method for Intervertebral Body Fusion Devices. Theacceptance criteria was/were met.
	• Static and dynamic compression shear testing in accordance with ASTM F-2077 Standard Test Method for Intervertebral Body Fusion Devices. Theacceptance criteria was/were met.
	• Subsidence testing in accordance with ASTM F-2267 Standard Test Methodfor Measuring Load Induced Subsidence of Intervertebral Body FusionDevice Under Static Axial Compression. The acceptance criteria was/weremet.
Clinical TestSummary:	No clinical tests were performed.
Conclusion:	Based on the predicate comparison and testing, the subject device DePuy PULSELumbar Cage System is substantially equivalent to the predicate devices.

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and the comments of the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings and a wavy line representing its body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medos International Sarl % Depuy Spine, A Johnson & Johnson Company Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

3 2012 JUL

Re: K120966

Trade/Device Name: DePuy PULSE™ Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 08, 2012 Received: June 11, 2012

Dear Mr. Bang:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Mr. Eugene Bang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Evinl Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: DePuy PULSE™ Lumbar Cage System

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use __

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120966

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.