The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

Device Description

The enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber. The enSpire™ Discectomy System is supplied as a sterile, single patient use, disposable device.

AI/ML Overview

The provided text describes a traditional 510(k) submission for the enSpire™ Discectomy System. This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML technology or studies typically associated with diagnostic algorithms. Therefore, much of the requested information regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's functional performance and non-clinical testing.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative "acceptance criteria" in a table format for specific performance metrics in the way one might expect for a diagnostic AI. Instead, the document states that the "enSpire™ Discectorny System meets the established specifications necessary for consistent performance during its intended use." The "reported device performance" is summarized by the successful completion of the non-clinical tests.

Performance Characteristic (Acceptance Criteria Implicitly Met)	Reported Device Performance (as stated in the document)
Tissue Removal efficacy	Demonstrated successful tissue removal.
No Breach of Annulus or Endplates	Successfully maintained integrity of annulus and endplates during operation.
Cannula Compatibility	Demonstrated compatibility with cannulas.
Enable Switch Durability	Switch showed sufficient durability.
Deployment & Retraction	Device demonstrated proper deployment and retraction.
Working Shaft Length Functionality	Functioned properly across its specified working lengths.
Device Durability	Device demonstrated satisfactory durability.
Travel Limiter Attachment Integrity	Travel limiter attachment was secure.
Travel Limiter Functionality	Travel limiter functioned as intended.
Tensile Strength	Met tensile strength requirements.
Articulation Function (if applicable for specific configurations)	Articulation function (for articulating models) performed as designed.
Articulation Angle (if applicable)	Achieved specified articulation angles.
Visualization capability	Provided adequate visualization.
Peak Temperature during Operation	Maintained acceptable peak temperatures during operation.
Electromagnetic Compatibility and Electrical Safety	Complied with EMC and electrical safety standards (e.g., IEC60601-1).
Packaging Integrity	Packaging maintained sterility and protected the device.
Shipping Stability	Device remained stable and functional after shipping.
Sterility (maintaining sterility)	Device maintained sterility (Gamma sterilized).
Shelf Life (maintaining functionality and sterility over time)	Demonstrated required shelf life.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity)	Demonstrated biocompatibility.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of in-vitro bench studies and non-clinical tests as summarized under "I. Summary of Non-Clinical Data" and detailed in the bulleted list.

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

Sample Size:
- For the non-clinical bench studies, the specific sample sizes for each test (e.g., number of devices tested for tissue removal, durability cycles) are not provided in this 510(k) summary.
Data Provenance: The studies were in-vitro bench studies, meaning they were conducted in a laboratory setting using simulated conditions or non-human tissue models, not from patient data. Therefore, "country of origin of the data" and "retrospective or prospective" do not apply in the context of patient data.

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

This information is not applicable as the studies were non-clinical bench tests evaluating device mechanics and functional performance, not diagnostic interpretations requiring expert ground truth in the medical sense.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical bench testing. Performance was assessed against predetermined engineering specifications and functional requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (surgical tool), not an AI/ML diagnostic or assistive technology.

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

Not applicable. This device is a mechanical surgical tool, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical studies, the "ground truth" was established by engineering specifications, functional requirements, and established industry standards (e.g., for biocompatibility, sterility, electrical safety). For example, "No Breach of Annulus or Endplates" is a direct performance criterion with no "expert consensus" needed beyond confirming the physical result.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm that requires training data.

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

Not applicable. (See point 8).

Summary

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Traditional 510(k) enSpire™ Discectomy System

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Name, Address, Phone and Fax Number of Applicant A.

Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: (510) 623-1931 (510) 490-1753 Fax:

B. Contact Person

Mbithi Muthini Director Quality and Regulatory (510) 743-5090 mmuthini@spineview.com

Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net

C. Date Prepared

April 7, 2011

D. Device Name

Trade Name:	enSpire™ Discectomy System
Common Name:	Arthroscope & Accessory
Classification Name:	Arthroscope & Accessories (21 CFR §888.1100, Product Code HRX)

E. Predicate Devices

The enSpire™ Discectomy System is substantially equivalent to the Spine View enSpire™ Debrider System cleared under K090278 on April 15, 2009.

· · ()

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Kllo992

Spine View, Inc.

F. Device Description

The enSpire™ Discectomy System is supplied as a sterile, single patient use, disposable device.

G. Intended Use

The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

H. Technological Comparison

The enSpire™ Discectomy System has similar features as compared to the predicate devices in the table below.

Feature	Spine View, Inc.Spine View ENSPIRE™ DebriderSystemK090278	Spine View, Inc.enSpire™ Discectomy SystemK110992
Indications for Use	The Spine View. ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.	The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.
Product Code	HRXArthroscope, 21CFR888.1100, Class II, (Debrider)NBH, Class I exempt (Introducer Cannula with Stylet)	HRXArthroscope, 21CFR888.1100, Class II, (Debrider)NBH, Class I exempt (Introducer Cannula with Stylet)
Principal Operator	Physician	Physician
Use Location	Operating Room or Medical Suite	Operating Room or Medical Suite
Operating Principal	Percutaneous, endoscopic or open surgical Discectomy system with standard surgical accessories	Percutaneous, endoscopic or open surgical Discectomy system with standard surgical accessories
Functions of IncludedDevices	DilatationAccessExcisionAspiration	DilatationAccessExcisionAspiration
Mechanics of Action	Percutaneous, endoscopic or open surgical Discectomy System with standard surgical accessories	Percutaneous, endoscopic or open surgical Discectomy System with standard surgical accessories
Target Anatomy	Intervertebral procedure	Intervertebral procedure
Design Features	Auger housed in a tube, with retractable cutting assembly (spiral	Auger housed in a tube, with retractable rotating cutting assembly (spiral wire or
Feature	Spine View, Inc.Spine View ENSPIRE™ DebriderSystemK090278	Spine View, Inc.enSpire™ Discectomy SystemK110992
	wire) on the distal end. It is driven bya battery-powered motor that ishoused in a plastic handle at theproximal end of the device.Cut debris can pass up the tube andinto the collection chamber located atthe end of the auger. It is insertedinto the surgical site either directly,via an introducer cannula orArthroscope.Working Shaft straight.	curette style cutter) on the distal end. Itis driven by a battery-powered motor thatis housed in a plastic handle at theproximal end of the device.Cut debris can pass up the tube and intothe collection chamber located at theend of the auger. It is inserted into thesurgical site either directly, via anintroducer cannula or Arthroscope.Working shaft: straight, curved orarticulating.
Tip Materials	Stainless Steel and Solder	PEEK, Aramid Fiber, Polyimide,Stainless Steel, and Tungsten
Sterile Packaging	The ENSPIRE™ Debrider System isplaced onto a polyethylene card andsealed in a Tyvek/Mylar pouch. Thatpouch is placed into a whiteboardunit carton.	The enSpire™ Discectomy System isplaced into a thermo formed tray with athermoformed insert lid, and sealed witha Tyvek tray lid. The sealed tray is thenplaced in a labeled chip board shelfcarton.
Sterilization Method	Electron Beam	Gamma
Biocompatible forIntended Use	Yes	Yes
Single use	Yes	Yes
Configuration	Straight	Straight, Curved, Articulating
Handle Design	Hand-held rotary device, in-line grip	Hand-held rotary device, in-line grip orpistol-grip
Profile	0.046" OD working shaft with tip0.27" OD deployed, 0.052" ODunexpanded.	0.046-0.165" OD working shaft with tip0.28-0.40" OD deployed, 0.058-0.22" ODunexpanded
Working Length	8 - 11" working length	2 - 22" working length
Energy Type	Mechanical	Mechanical
Power	Battery, 9V	Battery, 9V or 18V
Meets ApplicableIEC60601-1 testing	Yes	Yes
Uservisualization/guidance	Direct visualization, fluoroscopicimaging	Direct visualization, fluoroscopic imaging

Appendix A, Page 2 of 4

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Spine View, Inc.

Traditional 510(k) enSpire™ Discectomy System

The technological characteristics and principals of operation of the enSpire™ Discectomy System are substantially equivalent to the named predicate device.

l. Summary of Non-Clinical Data

The enSpire™ Discectomy System performance characteristics were evaluated in the following in-vitro bench studies:

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4110992

Spine View, Inc.

Traditional 510(k) enSpire™ Discectomy System

Tissue Removal ●
Cannula Compatibility .
Enable Switch Durability .
. Deployment & Retraction
Working Shaft Length .
. Device Durability
. Travel Limiter Attachment
. Travel Limiter
Tensile Strength .
Articulation Function .
. Articulation Angle
Visualization .
Peak Temperature during . Operation

Tissue Volume/Material Removal

No Breach of Annulus or Endplates

· Electromagnetic Compatibility and Electrical Safety
· Packaging Testing
· Shipping Testing
· Sterility Testing
· Shelf Life Testing
· Biocompatibility:
- Cytotoxicity o
- Sensitization O
- Irritation 0
- Systemic Toxicity 0

Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the enSpire™ Discectorny System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the enSpire™ Discectomy System is substantially equivalent to the named predicate.

J. Summary of Data

The enSpire™ Discectomy System has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the enSpire™ Discectorny System performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the enSpire™ Discectomy System is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus, indicating the department's name and country.

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

OCT 2 1 2011

Spine View, Inc. % Mr. Mbithi Muthini Director, Quality and Regulatory 48810 Kato Road, Suite 100E Fremont, California 94538

Re: K110992

Trade/Device Name: enSpire™ Discectomy System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 20, 2011 Received: September 22, 2011

Dear Mr. Muthini:

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 Amendmouts, 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.

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

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Page 2 - Mr. Mbithi Muthini

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.

Eriel Keith

Cor 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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Spine View, Inc.

Indications for Use Statement

510(k) Number (if known):

K110992 K

Device Name: enSpire™ Discectomy System

Indications for Use:

The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

Prescription Use × OR

Over-The-Counter Use

(per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Ogden for MKN
Division Sign Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110992

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.