The SPOTLIGHTTM Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the posterior and posterolateral bony spinal elements. These ports provide access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.

Device Description

The SPOTLIGHT™ Access System consists of a series of dilators and tubular retractors with and without integrated light source of various lengths and diameters designed to provide minimally invasive surgical access to the spine. The SPOTLIGHT™ Access System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SPOTLIGHT™ Access System:

This document describes a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials. Therefore, the "study" described here is primarily a series of engineering and biocompatibility tests designed to show the new device performs similarly to or better than the predicate.

1. Acceptance Criteria and Reported Device Performance

Test System	Acceptance Criteria (Implied by "Pass" or "Conforms")	Reported Device Performance
Compressive Force Testing	Met the same specification as the predicate device	Met the same specification as the predicate device
Static Torque Testing on Fixed Handle Connection	All samples met the acceptance criteria	All samples met the acceptance criteria
Validation of Reprocessing Instructions	Equivalency to previously validated devices for cleaning and sterilization	An evaluation of the devices for equivalency to previously validated devices for reprocessing cleaning and sterilization was performed and documented according to DePuy Spine, Inc. internal procedures.
USP Physiochemical Test for Plastics	Non-volatile Residue - ConformsResidue on Ignition - ConformsHeavy Metals - ConformsBuffering Capacity - Conforms	Non-volatile Residue - ConformsResidue on Ignition - ConformsHeavy Metals - ConformsBuffering Capacity - Conforms
In vitro Cytotoxicity Agar Diffusion	Non-cytotoxic	Cell culture treated with test sample exhibited Slight (Grade I) Reactivity
In vitro Cytotoxicity MEM Elution Test	Non-cytotoxic	Cell culture treated with sample extract exhibited no cells lysis (Grade 0 Reactivity)
Sensitization Test - Guinea Pig Maximization	Non-sensitizing (No significant difference in biological response between test article and negative control)	No significant difference in biological response between test article and negative control.
Irritation/Intracutaneous Reactivity USP Intracutaneous Test	Non-irritating (Difference between mean scores for sample extracts and corresponding blanks 0.5 or less)	The difference between the mean scores for the sample extracts and corresponding blanks was 0.5 or less.
Acute Systemic Toxicity USP Systemic Injection Test	Non-toxic (No signs of toxicity, all gained weight)	None of the animals treated with the sample extracts showed any signs of toxicity and all gained weight.
In vitro Genotoxicity - Ames Bacterial Mutagenicity Assay	Non-mutagenic (None of the five tester strains produced two-fold increases in the number of revertants; no zone of increased reversion or inhibition)	None of the five tester strains produced two-fold increases in the number of revertants. The spot tests showed no zone of increased reversion or of inhibition.
Implantation USP Implantation Test	Met the requirements of the USP Implantation Test when implanted for seven days (No encapsulation observed grossly, no irritation microscopically)	No encapsulation was observed grossly in any of the test or control sites, and no irritation was observed microscopically at the test sites compared to the control sites.
In vitro Hemolysis Extraction Method	Non-hemolytic (Less than 5% hemolysis)	Less than 5% hemolysis- A test sample with 5% or less hemolysis is considered non-hemolytic.
In vitro Hemolysis Direct Contact	Non-hemolytic (Less than 5% hemolysis)	Less than 5% hemolysis- A test sample with 5% or less hemolysis is considered non-hemolytic.
Material-Mediated Pyrogenicity USP Rabbit Pyrogen Test	Non-pyrogenic (No rabbit showed an individual rise in temperature of 0.5°C or more)	No rabbit showed an individual rise in temperature of 0.5°C or more.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state sample sizes for each test in numerical terms (e.g., "n=X units"). However, for tests like "Static Torque Testing on Fixed Handle Connection," it states "All samples met the acceptance criteria," implying a sample was tested. For animal studies (e.g., Guinea Pig Maximization, USP Systemic Injection Test, USP Rabbit Pyrogen Test), it refers to "animals" but does not give a specific number.

Sample Size: Not explicitly quantified in numerical terms for most tests. General phrasing "All samples" or "None of the animals" is used.
Data Provenance: The document does not specify the country of origin of the data. Given it's a submission to the U.S. Food and Drug Administration, it's likely conducted in compliance with US or internationally recognized standards (e.g., ASTM, USP). The studies appear to be retrospective in the sense that they are conducted on manufactured devices or materials to demonstrate compliance.

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

N/A. This type of submission (510(k) for a surgical access system) relies on engineering and biocompatibility testing against established standards, not expert clinical interpretation of results. Therefore, no "medical experts" were used to establish ground truth in the way one would for diagnostic imaging. The "ground truth" is defined by the technical specifications and biological standards (e.g., USP standards) themselves.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. The tests presented here are objective, quantitative, or qualitative assessments against predefined scientific/engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No. A MRMC comparative effectiveness study is designed to assess the performance of diagnostic devices often with human interpretation. This document pertains to a surgical access system where efficacy is demonstrated through mechanical and biological safety testing, not diagnostic accuracy.

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

N/A. The "SPOTLIGHT™ Access System" is a physical surgical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The tests described are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth for these tests is based on established scientific and engineering standards and specifications.

Engineering Specifications: For tests like Compressive Force and Static Torque, the "ground truth" is the predefined mechanical performance requirement, often derived from predicate device performance.
Biological Standards: For biocompatibility tests (e.g., Cytotoxicity, Pyrogenicity, Implantation), the "ground truth" is defined by widely accepted standards, particularly those published by the United States Pharmacopeia (USP) and relevant ISO standards (though not explicitly listed, USP often aligns with ISO for biological evaluations). These standards define what constitutes "non-toxic," "non-irritating," etc.

8. The Sample Size for the Training Set

N/A. This device is not an AI/ML algorithm, so there is no concept of a "training set" in the context of model development. The manufacturing processes and material selection might be informed by historical data, but not in the sense of a machine learning training set.

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

N/A. As there is no AI/ML training set, this question is not applicable.

Summary

{0}------------------------------------------------

KIT2913

510(K) SUMMARY

DEC 1 6 2011

Submitter Information A.

DePuy Spine, Inc. . 325 Paramount Drive Raynham, MA 02767

Contact Person: Address:

Telephone number:

Fax number:

Laura Bleyendaal 325 Paramount Drive Raynham, MA 02767 (508) 828-3267 (508) 828-3797 LBleyend@its.jnj.com

December 8, 2011

Date Prepared B.

Email:

C. Device Name

SPOTLIGHTTM Access System Trade/Proprietary Name: Self-retaining retractor for neurosurgery Common/Usual Name: Retractor, Self-Retaining, For Neurosurgery Classification Name: per 21 CFR § 882.4800

Predicate Device Name D.

DePuy Spine, Inc. SPOTLIGHT™ Access System (K062814) Trade name: Bright Medical Dilation Retractor System (K992898)

Device Description E.

DePuy Spine, Inc., a Johnson & Johnson Company

Page 1

{1}------------------------------------------------

Intended Use F.

The SPOTLIGHT™ Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the posterior and posterolateral bony spinal elements. These ports provide access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.

Summary of Similarities and Differences in Technological Characteristics F.

The wall thickness of the proposed ports varies from the i. proximal to the distal end. The wall thickness of the proposed ports is less than that of the previously cleared SPOTLIGHT™ Access System ports and greater than that of the previously cleared Bright Medical Dilation Retractor System ports.
The proposed ports have a permanently fixed handle at the ii. proximal end for manual manipulation.
Like the previously cleared Bright Medical Dilation iii. Retractor System ports, the proposed ports do not contain an integrated light source.
The proposed port lengths and outer diameters are iv. consistent with previously cleared SPOTLIGHT™ Access System port offerings.
The proposed ports are manufactured from a different v. material (anodized 6061 T6 aluminum) than the previously cleared SPOTLIGHT™ Access System ports and Bright Medical Dilation Retractor System ports.

Materials G.

The subject ports are manufactured from anodized 6061 T6 aluminum. The material conforms to the following ASTM standards: B211 and B221.

{2}------------------------------------------------

H. Performance Data

Test System	Study Results	Conclusion
Compressive ForceTesting	Met the same specification as thepredicate device	Pass
Static Torque Testingon Fixed HandleConnection	All samples met the acceptancecriteria	Pass
Validation ofReprocessingInstructions	An evaluation of the devices forequivalency to previously validateddevices for reprocessing cleaningand sterilization was performed anddocumented according to DePuySpine, Inc. internal procedures.	Pass
USP PhysiochemicalTest for Plastics	Non-volatile Residue- ConformsResidue on Ignition- ConformsHeavy Metals- ConformsBuffering Capacity- Conforms	Conforms- passesall acceptancecriteria
In vitro CytotoxicityAgar Diffusion	Cell culture treated with testsample exhibited Slight (Grade I)Reactivity	Non-cytotoxic
In vitro CytotoxicityMEM Elution Test	Cell culture treated with sampleextract exhibited no cells lysis(Grade 0 Reactivity)	Non-cytotoxic
Sensitization Test -Guinea PigMaximization	No significant difference inbiological response between testarticle and negative control.	Non- sensitizing
Irritation/IntracutaneousReactivityUSP IntracutaneousTest	The difference between the meanscores for the sample extracts andcorresponding blanks was 0.5 orless.	Non-irritating
Acute SystemicToxicityUSP Systemic InjectionTest	None of the animals treated withthe sample extracts showed anysigns of toxicity and all gainedweight.	Non-toxic
In vitro Genotoxicity -Ames BacterialMutagenicity Assay	None of the five tester strainsproduced two-fold increases in thenumber of revertants. The spottests showed no zone of increasedreversion or of inhibition.	Non-mutagenic
ImplantationUSP Implantation Test	No encapsulation was observedgrossly in any of the test or controlsites, and no irritation wasobserved microscopically at the testsites compared to the control sites.	The test materialmet therequirements ofthe USPImplantation Testwhen implantedfor seven days
In vitro HemolysisExtraction Method	Less than 5% hemolysis- A testsample with 5% or less hemolysisis considered non-hemolytic.	Non-hemolytic
In vitro HemolysisDirect Contact	Less than 5% hemolysis- A testsample with 5% or less hemolysisis considered non-hemolytic.	Non-hemolytic
Material-MediatedPyrogenicityUSP Rabbit PyrogenTest	No rabbit showed an individual risein temperature of 0.5°C or more.	Non-pyrogenic

DePuy Spine, Inc., a Johnson & Johnson Company

Page 3

{3}------------------------------------------------

I. Conclusion

Both the performance testing and substantial equivalence justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Page 4

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

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

DEC 1 6 2011

Johnson & Johnson c/o Ms. Laura Bleyendaal Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K112913

Trade/Device Name: SPOTLIGHT™ Access System Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: Class II Product Code: GZT Dated: December 1, 2011 Received: December 2, 2011

Dear Ms. Bleyendaal:

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.

{5}------------------------------------------------

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number: K112913

Device Name: SPOTLIGHTTM Access System

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JEFFREY TOY

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number__

K112913

Regulation Number and Section

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).