The Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Device Description

The Minimally Invasive Surgical (MIS) Decompression System is a collection of arthroscopic surgical accessories provided sterile (irradiated) and intended for single-use only. As a group, the accessories are provided to facilitate delivery of an endoscope and other instruments to the targeted treatment site. The addition of a new accessory, the enCise Bone Cutter, as an additional surgical tool to facilitate removal of soft and hard (bone) tissue during interventional spinal procedures. The new component will be offered in two configurations: one compatible with flexible endoscopes, and the second compatible with rigid endoscopes. Two additional enVue Cannula models are also being introduced for compatibility with rigid endoscopes: Long and Standard Jaw. Introduction of the new enCise Bone Cutter and additional configurations of the already cleared enVue Cannula do not affect the intended use or alter the fundamental scientific technology of the system.

The additional accessories being proposed in the modified MIS Decompression System are listed below:

. enCise Bone Cutter: a tubular sheath with a mechanical "chisel" tip feature designed to cut soft and hard (cartilaginous, bone) tissue during spinal procedures. The enCise Bone Cutter is offered in two configurations (one compatible with flexible endoscopes, and the second compatible with rigid endoscopes).
enVue Cannula, Standard and Long Jaw: configurations for use with rigid . endoscopes. The working end of the accessories is identical to the previously cleared enVue Cannulas. The only difference is in the handle, which is modified to accommodate rigid endoscopes (up to 5.9 mm OD; 205 mm working length).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Spine View, Inc. Minimally Invasive Surgical (MIS) Decompression System:

Based on the provided 510(k) Summary (K121548), the device in question is a minimally invasive surgical system, and the filing primarily focuses on demonstrating substantial equivalence to predicate devices for specific new accessories (enCise Bone Cutter, and new enVue Cannula configurations). This type of submission generally relies on non-clinical performance data to show that the new components perform as intended and do not raise new questions of safety or effectiveness compared to legally marketed devices. It is not a study about the performance of an AI/ML algorithm. Therefore, many of the requested categories regarding AI-specific studies, ground truth establishment, expert consensus, and reader studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in terms of specific thresholds for performance metrics. Instead, it refers to validation against "product specifications and external standard requirements" and aims to demonstrate "substantial equivalence" to predicate devices. The "reported device performance" is summarized as the successful completion of various non-clinical tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Device functions according to stated intended use	"The above testing confirmed that the Spine View Minimally Invasive Surgical (MIS). Decompression System performs according to the stated intended use."
All data falls within product specifications	"All data fell well within product specifications..."
All data falls within external standard requirements	"...and external standard requirements."
Maintains substantial equivalence to predicate devices	"Results of non-clinical testing demonstrated that the Spine View Minimally Invasive Surgical (MIS) Decompression System is substantially equivalent to the predicate devices for its intended use."
Performance of specific non-clinical tests is satisfactory	Successful completion of: Device to Device Compatibility, Joint Integrity, Tip Rotation, Tip Robustness, Handle/Joint Integrity, Jaw & Trigger Force, Jaw Cycle Integrity, Jaw Activation, Biocompatibility, Design Validation, Packaging, Sterility Testing.

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

This information is not applicable as the submission describes non-clinical performance testing of mechanical components, not an AI/ML algorithm or a study with a "test set" of patient data. The tests would likely involve prototypes or production units of the device components. There is no mention of country of origin of data or retrospective/prospective in this context.

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

This information is not applicable. The ground truth for this type of medical device submission is typically established through engineering specifications, material science standards, and established biocompatibility principles, performed by qualified engineers and scientists. There are no "patient cases" or an "AI test set" requiring clinical expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "test set" in the context of clinical data requiring adjudication.

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

This information is not applicable. No AI/ML algorithm is involved in this device submission. This is a special 510(k) for mechanical surgical instruments.

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

This information is not applicable. No AI/ML algorithm is involved in this device submission.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" is based on:

Engineering specifications and design requirements: Each test would have a pre-defined performance envelope or target.
External standards: Relevant ISO standards, ASTM standards, or other industry benchmarks for material properties, sterility, biocompatibility, and mechanical performance.
Predicate device characteristics: To demonstrate substantial equivalence, the performance of the new device is compared against the known performance and characteristics of the predicate devices.

8. The sample size for the training set

This information is not applicable. There is no AI/ML algorithm and therefore no "training set" of data in this submission.

9. How the ground truth for the training set was established

This information is not applicable. There is no AI/ML algorithm and therefore no "training set." The ground truth for the design and testing of the mechanical device is established through engineering principles, material science, and regulatory standards as described in point 7.

Summary

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121548

Spine View, Inc.

Special 510(k) Notification Minimally Invasive Surgical (MIS) Decompression System

510(k) Summary

AUG 1 6 2012

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 and Address of Applicant A. Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: (510) 743-5090 Fax: (510) 490-1753

B. Contact Person

Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant Phone: (925) 980-8047

C. Date Prepared
July 13, 2012
D. Device Name
Minimally Invasive Surgical (MIS) Decompression System Trade Name: Common Name: Arthroscope Classification Name: · Arthroscope

ய் Device Classification

Classification:	21 CFR §888.1100
Product Code:	HRX
Device Class:	Class II

F. Predicate Device

The modified Minimally Invasive Surgical (MIS) Decompression System is substantially equivalent to the Spine View SpineVu Endoscopic Spine System (SESS) (K113362 and K08151) and predicate cutting instruments offered as part of the Richard Wolf Medical Instruments Corp. Minimally Invasive Spinal Surgery Set (K994363) and several Class I orthopedic manual surgical instruments, including the Joimax EndoReamer and EndoChisel Assembly.

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KIZISY8

Spine View, Inc.

Special 510(k) Notification Minimally Invasive Surgical (MIS) Decompression System

G. Device Description

The additional accessories being proposed in the modified MIS Decompression System are listed below:

. enCise Bone Cutter: a tubular sheath with a mechanical "chisel" tip feature designed to cut soft and hard (cartilaginous, bone) tissue during spinal procedures. The enCise Bone Cutter is offered in two configurations (one compatible with flexible endoscopes, and the second compatible with rigid endoscopes).
enVue Cannula, Standard and Long Jaw: configurations for use with rigid . endoscopes. The working end of the accessories is identical to the previously cleared enVue Cannulas. The only difference is in the handle, which is modified to accommodate rigid endoscopes (up to 5.9 mm OD; 205 mm working length).

H. Intended Use

l. Technological Comparison

The Spine View Minimally Invasive Surgical (MIS) Decompression System has similar features as compared to the predicate devices as shown in the tables below:

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K121548 f-3.0+5

Spine View, Inc.

enCise Bone Cutter

	Predicate	Predicate	Subject
Company, K#	Richard Wolf MinimallyInvasive Spinal SurgerySet,K994363	Joimax, Inc., TESSYSSurgical Instruments, N/A- Class I Exempt	Spine View MISDecompression System,K121548
Device Name	Punches	EndoReamer, EndoChisel	enCise Bone Cutter
Intended Use	endoscopically controlleddissection, exploration, andmanipulation of tissuethrough natural or surgicallycreated passagesto grasp, manipulate, andcut, as well as for thedissection and biopsy oftissue, organs, or foreignbodies.punching and removal oftissue through natural orsurgically created passages.	The Joimax TESSYS SpinalStenosis System is a set ofendoscopic instruments thatfacilitate removal ofosseous/bony materialunder direct endoscopicimaging. The EndoReamerand EndoChisel instrumentsare intended to removeosteophytes and calcifyingtissues, including coarsestenosis fragments.	enCise Bone Cutter isintended to facilitateremoval of removeosteophytes and calcifyingtissues under directendoscopic visualization.
Product Code	HRX, Class II	LXH, Class I - 510(k)Exempt	HRX, Class II
Design	The punch-featuredinstruments are designedwith a sliding jaw, which isforced into the material to becut by depressing themechanical actuator in thehandle	The chisel-featuredinstruments are designedwith a characteristicallyshaped cutting edge, whichare forced into the materialto be cut by use of asurgical mallet or manualmanipulation	Same
Dimensions	2.5 - 4.0 mm OD, WL 290 -360 mm (=2.5-4.0 mmcutting element tip width)	EndoReamer: SingleWorking Channel forendoscope and endoscopicinstruments3.0-7.5 mm ID; 4.0-8.5 mmOD; WL 210 mm (4.0 -8.5mm circular serrated tipdiameter)EndoChisel: 2.6 or 3.0 mmOD, WL 370 mm (=2.6 or3.0 mm chisel tip width)	Single Working Channel forendoscope and endoscopicinstruments6.12 mm ID, 7.16 mm OD,196 &198 mm WL (3.76 mmchisel tip width)
Patient Contact Materials	Stainless Steel	Same	Same
Target Anatomy	Intervertebral procedures	Same	Same
Supplied Sterile?	No	No	Yes
Single Use?	No	No	Yes
	Predicate	Subject
Company, K#	Spine View, MIS Decompression SystemK113362	Spine View, MIS Decompression SystemK121548
Device Name	enVue Cannula	enVue Cannula
Intended Use	1. Access cannula with working channel forendoscope, endoscopic instruments, andirrigation and drainage2. Distal feature for retracting tissue awayfrom end of cannula	1. Same2. Same
Product Code	HRX, Class II	Same
Design	Articulating Top Jaw can be mechanicallyactuated to retract tissue away from end ofcannula Distal tip: Articulating jaw (Nylon) fortissue retraction (Standard and Long jawconfigurations)	Same
Dimensions	1. OD: 0.282"2. Working Length: 7.5"3. Length, Tissue Retraction Feature 0.394"4. OD, Tissue Retraction Feature: 0.354 "5. Single Working Channel 0.240" for enVueSheath (for endoscopic instruments andendoscope [2 mm OD]	1. Same2. Same3. Same4. Same5. Single Working Channel 0.240" forendoscopic instruments and endoscope [5.9mm OD]
Patient ContactMaterials	Stainless Steel, Nylon-12	Same
Target Anatomy	Intervertebral procedures	Same
SuppliedSterile?	Yes	Same
Single Use?	Yes	Same

. :

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K1215468 g. 4 c of 5

Spine View, Inc.

Special 510(k) Notification SpineVu Endoscopic Spine System (SESS)

enVue Cannula

The technological characteristics and principals of operation of the modified Spine View Minimally Invasive Surgical (MIS) Decompression System are substantially equivalent to the named predicate devices. .

J. Non-Clinical Performance Data

The following non-clinical testing was conducted to support a determination of substantial equivalence to the predicate device.

• Device to Device Compatibility Testing	• Jaw Cycle Integrity Testing
• Joint Integrity Testing	• Jaw Activation Testing
• Tip Rotation	• Biocompatibility Testing
• Tip Robustness	• Design Validation Testing
• Handle/Joint Integrity	• Packaging Testing
• Jaw & Trigger Force Testing	• Sterility Testing

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1215486- 5 of J

Spine View, Inc.

The above testing confirmed that the Spine View Minimally Invasive Surgical (MIS). Decompression System performs according to the stated intended use. All data fell well within product specifications and external standard requirements. Results of non-clinical testing demonstrated that the Spine View Minimally Invasive Surgical (MIS) Decompression System is substantially equivalent to the predicate devices for its intended use.

K. Conclusions

The Spine View Minimally Invasive Surgical (MIS) Decompression System has been carefully compared to legally marketed devices 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 modified Spine View Minimally Invasive Surgical (MIS) Decompression System functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device for its intended use.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

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

Spine View, Incorporated % Ms. Diana DeGregorio Regulatory Affairs Consultant 48810 Kato Road, Suite 100E Fremont, California 94538

Re: K121548

Trade/Device Name: Minimally Invasive Surgical (MIS) Decompression System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: July 15, 2012 Received: July 18, 2012

Dear Ms. DeGregorio:

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.

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

AUG 16 2012

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Page 2 - Ms. Diana DeGregorio

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 yours

For Duth.

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.

K121548 p. 1 o f 1

Indications for Use Statement

510(k) Number (if known):

Device Name: Minimally Invasive Surgical (MIS) Decompression System

Indications for Use:

Prescription Use × 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)

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.