The XTEND-ST Nucleus Removal System is intended to resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space.
The XTEND-ST Nucleus Removal System is indicated to resect damaged or diseased intervertebral nucleus pulposus material found in the adult lumbar disc space.

Device Description

The CoreSpine XTEND-ST Nucleus Removal System is a soft tissue removal device that is comprised of a disposable, sterile handheid nucleus tissue cutting device, a table-top electronic control unit, and a foot pedal. The tip of the XTEND-ST cutting device can articulate and extend within the disc cavity providing an ability to reach areas of the disc that are otherwise unreachable with a rongeur. Cut tissue is continuously suctioned through a central lumen using a standard vacuum designed to minimize clogging. The XTEND-ST Nucleus Removal System is intended to effectively and efficiently prepare the disc space without damaging the annulus or endplates in preparation for a spinal implant or other therapy.
The XTEND-ST cutting device is made from a stainless steel rotary cutting mechanism with a motor housed in a plastic handle.

AI/ML Overview

The XTEND-ST™ Nucleus Removal System is a medical device intended to resect damaged or diseased nucleus pulposus material in the adult lumbar disc space. The provided text, a 510(k) summary, outlines the non-clinical testing performed to demonstrate its safety and performance and establish substantial equivalence to predicate devices. However, it does not explicitly define acceptance criteria in a quantitative table or detail a specific study proving the device met these criteria in a structured manner often seen with AI/software medical devices.

Instead, the submission focuses on demonstrating general safety and performance through a series of tests, concluding that these studies showed substantial equivalence.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary for a mechanical device, explicit quantitative acceptance criteria for each test are not listed. Instead, the "reported device performance" is largely qualitative, asserting that the device met the requirements.

Acceptance Criteria Category	Reported Device Performance	Study Type to Meet Criteria
Biocompatibility	Appropriate levels of biocompatibility demonstrated.	Material Selection & Biocompatibility Testing (implied)
Electrical Safety	System met test limits for safety and conforms to immunity and emissions requirements.	Electrical Testing (per IEC 60601-1)
Electromagnetic Compatibility (EMC)	Conforms to immunity and emissions requirements.	Electrical Testing (per IEC 60601-1)
Human Factors	Acceptable human factors features in device functioning and labeling.	Human Factor Analysis
Performance (Tissue Removal)	Ensures performance and safety; demonstrates substantial equivalence to commercially cleared tissue removal devices.	Bench Testing & Cadaver Testing
Safety	No new risks or efficacy concerns beyond predicate devices; safe for intended use.	Bench Testing & Cadaver Testing
Functionality (Design Specifications)	Device functions as intended and meets design specifications.	Non-clinical testing (General Statement)

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

Sample Sizes: The document does not specify exact sample sizes for any of the tests (e.g., number of units tested for electrical safety, number of cadavers used, number of human factor participants).
Data Provenance: Not explicitly stated, but clinical data (if any) would typically be from surgical settings. The stated tests are "non-clinical," implying laboratory or simulated environments. "Cadaver testing" implies biological samples, likely from human donors, but the origin country is not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable / Not Stated Directly: For this type of mechanical device submission, "ground truth" as it pertains to expert consensus on diagnostic imaging or clinical outcomes (as implied by the question) is not directly applicable in the same way it would be for an AI algorithm.
The human factor analysis likely involved experts in human factors engineering and user experience, but their number and specific qualifications are not detailed.
Cadaver testing would have involved medical professionals (e.g., orthopedic surgeons, anatomists) to assess the device's performance, but their number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

Not Applicable / Not Stated: The concept of an adjudication method (like 2+1 or 3+1 consensus) is typically used when establishing a ground truth from expert opinions, often for diagnostic accuracy studies. This is not described for the non-clinical testing of this mechanical device. The "conclusion" of each test (e.g., "met the test limits," "demonstrated appropriate levels") implies an evaluation against predefined benchmarks, but a multi-expert adjudication process is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. These studies are typically used for evaluating the impact of diagnostic aids (like AI) on physician performance. This device is a surgical tool, not a diagnostic aid.

6. Standalone (Algorithm Only) Performance Study

No: This is a mechanical surgical device, not a software algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable. The device's performance was assessed during "bench testing" and "cadaver testing," which are "standalone" in the sense that the device was evaluated without human-in-the-loop diagnostic assistance, but always with a human operating the device as it's a surgical tool.

7. Type of Ground Truth Used

For Biocompatibility: Material specifications and ISO standards for biocompatibility (implied).
For Electrical Safety/EMC: IEC 60601-1 standards and associated test limits.
For Human Factors: Principles of human-device interaction, usability criteria (implied by "acceptable human factors features").
For Performance (Bench/Cadaver Testing): Engineering specifications, anatomical integrity (e.g., not damaging annulus or endplates), effectiveness of tissue removal (implied by "effectively and efficiently prepare the disc space"), and comparison to predicate device performance. Direct "pathology" or "outcomes data" in the typical clinical trial sense are not described for these non-clinical tests.

8. Sample Size for the Training Set

Not Applicable: This is a mechanical device, not an AI algorithm, so there is no "training set."

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

Not Applicable: As there is no training set for an AI algorithm, this question is not applicable.

Summary

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K090303

APR 3 0 2009

510(k) Summary (per 21 CFR 807.87(h))

Common/Usual Name:	Arthroscopic Accessory: Articulating and ExtendibleShaver
Product Trade Name:	XTEND-ST™ Nucleus Removal System
Classification Name:	Arthroscope and AccessoryClass II per 21 CFR § 888.1100Product Code HRX
. Predicate Device:	Endius, Inc. FlexTip Blade, K022578Clarus Medical, LLC. Nucleotome Probe Set,K040919HydroCision, Inc. Arthrojet System, K041233
Manufacturer:	CoreSpine Technologies, LLC5909 Baker Road, Suite 550Minneapolis, MN 55345
Contact:	Britt K. NortonFounder and Chief Operating Officer
Date Prepared:	January 30, 2009

Device Description:

The XTEND-ST cutting device is made from a stainless steel rotary cutting mechanism with a motor housed in a plastic handle.

Indications for Use:

The XTEND-ST Nucleus Removal System is intended to resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space.

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$$\vdash$$

Comparison of technological characteristics:

Substantial equivalence of the XTEND-ST Nucleus Removal System with the predicate devices is based on similar intended use/indications for use, design, function and materials of construction. The XTEND-ST Nucleus Removal System and the predicate devices are all intended to remove soft tissue during surgery. However the XTEND ST cutter tip extends along its axis, whereas the predicate devices do not. Verification and validation studies performed on the XTEND-ST Nucleus Removal System demonstrated that this difference does not negatively affect the safety and performance of the device when used as intended.

Summary of Non-Clinical Testing:

The biological safety of the XTEND-ST cutting device was achieved through the selection of materials that demonstrated appropriate levels of biocompatibility.

Electrical testing was performed on the XTEND-ST Nucleus Removal System per IEC 60601-1 to demonstrate electrical safety, and the result showed the system met the test limits as described for safety testing and conforms to the immunity and emissions requirements for electromagnetic compatibility.

Human factor analysis was conducted and concluded that the XTEND-ST Nucleus Removal System presented acceptable human factors features in both the functioning of the device and usage of the labeling.

Bench testing and cadaver testing were conducted to ensure the performance and safety of the XTEND-ST Nucleus Removal System and to demonstrate substantial equivalent to other commercially cleared tissue removal devices available for sale in the USA.

No new risks or efficacy concerns other than those identified with the predicate device were raised. Results of non-clinical testing demonstrated that the XTEND-ST System is safe and effective for its intended use.

Conclusion:

The XTEND-ST Nucleus Removal System has similar intended use, material biosafety profile, and technical characteristics as the predicate devices. Non-clinical testing was conducted to verify the safety and performance of the XTEND-ST Nucleus Removal System and to ensure the device functions as intended and meets design specifications. As a result, the XTEND-ST Nucleus Removal System has been demonstrated to be substantially equivalent to the predicate devices and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus, a symbol of medicine, in its talons.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2009

Re: K090303

CoreSpine Technologies, LLC

% Mr. Britt K. Norton 5909 Baker Road, Suite 550 Minneapolis, Minnesota 55345

Trade/Device Name: XTEND-ST™ Nucleus Removal System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: April 13, 2009 Received: April 14, 2009

Dear Mr. Britt:

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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to

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Page 2 - Mr. Britt K. Norton

premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milliman

Mark N. Melkerson 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 STATEMENT

(090303

Current 510(k) Number: __

Device Name:

XTEND-ST™ Nucleus Removal System

Indications for Use:

The XTEND-ST Nucleus Removal System is indicated to resect damaged or diseased intervertebral nucleus pulposus material found in the adult lumbar disc space.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number 0000000

NewroldscipolouwsN bus The submisted for starters for and the

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.