The maxMorespine Endoscope when used with recommended third party accessories/components, is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy and foraminotomy.

Device Description

The maxMorespine Endoscope is a rigid, multi-channel endoscope comprised of a working channel, rod lens optical system to transmit light and images with irrigation channel(s) and stopcocks. The body is designed of an outer and inner tube of surgical grade stainless steel. The proximal end of the endoscope; eyepiece and light post is adaptable to industry standard endoscopic camera and light systems. The endoscope will be introduced into the patient via a minimally invasive access through a working cannula with various instruments introduced through the Endoscope working channel (maxMorespine System submitted sepatately - K090132).

AI/ML Overview

This document is a 510(k) premarket notification for the maxMorespine Endoscope. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about a study to prove acceptance criteria for device performance. It's a regulatory submission for a medical device cleared in 2009.

Therefore, I cannot provide the requested information, which typically applies to AI/ML software as a medical device (SaMD) or devices with performance claims that require clinical or analytical validation studies.

Here's why the requested information isn't present in the provided document:

Nature of the Device: The maxMorespine Endoscope is a physical, rigid multi-channel endoscope. Its performance is primarily assessed through design specifications, material compatibility, and intended use, rather than complex algorithms requiring validation against ground truth data.
510(k) Paradigm for this Device Type: For devices like endoscopes, substantial equivalence is usually demonstrated by comparing design, materials, sterilization, and intended use to existing predicate devices already on the market. This often doesn't involve formal performance studies with acceptance criteria in the same way an AI/ML diagnostic tool would.
Absence of Software: The document explicitly states, "No Software is needed for the maxMorespine Endoscope" (page 2), eliminating the need for AI/ML specific validation criteria.
Date of Submission: This submission is from 2009, prior to the widespread adoption and regulatory focus on AI/ML in medical devices that necessitated the detailed performance study information you're requesting.

In summary, the provided document does not contain any of the requested information regarding acceptance criteria or a study proving device performance because it pertains to a traditional medical device (an endoscope) for which such studies are typically not required for 510(k) clearance, particularly in 2009, and it has no AI/ML component.

Summary

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pg 1 of 2

maxMorespine Endoscope

Section 1.0 510(k) Summarv

as required by section 807.92(c)

maxMorespine Endoscope

OCT - 9 2009

1.1

Submitter Information

Hoogland Spine Products GmbH Feringastr. 7a D-85774 Unterföhring - Germany +49 (0) 89 21 58 960 - 20 Phone No.: +49 (0) 89 21 58 960 - 98 Fax No.:

USA Agent

Spine Now, LLC 94 Gardiners Ave, #307 Levittown, NY 11756 Phone No .: (888) 994-3335 (516) 277-0065 Fax No.:

Contact Information

Joan L. Carter - President, Spine Now, LLC. Phone No.: (516) 721-7442 E-mail: jcarter@spinenow.com

1.2 Establishment / Owner Information Hoogland Spine Products GmbH Feringastr. 7a D-85774 Unterföhring - Germany
FDA Establishment Registration Number 30065611611
1.3 Proprietary Name maxMorespine Endoscope TOM Endoscope

1.4 Common Name Spinal Endoscope

Classification Name 4.5 Arthroscope and accessories
1.6 Regulation Number 21 CFR 888.1100

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3552 pg 2 of 2

maxMorespine Endoscope

1.7 Requiatory Class Class II

ﺎ

4.8 Classification Product Code HRX

1.9 Intended Use

1.10 Device Description / Technology Characteristics

Substantial Equivalence 1.11

The maxMorespine TOM Endoscope is substantially equivalent in purpose, design, materials and function to the following marketed products:

Joimax THESSYS Multiscope (K051827)
RIchard Wolf Yeung Endoscopic Spine System (K973405)
Arthro Kinetics' Endoscopic Spine System (K061246)

1.12 Sterilization

maxMorespine Endoscopes will be sold non-sterile, to be sterilized prior to each procedure by the user. Sterilization instructions are provided in the Instructions for Use (see Section 2.4)

1.13 Software

No Software is needed for the maxMorespine Endoscope

1.14 Conclusion

The specifications and intended use of the maxMorespine Endoscope is the same as those of the claimed predicate devices. There are no significant differences in design or manufacturing materials between the maxMorespine Endoscope and predicate devices. In all aspects, the maxMorespine Endoscope is substantially equivalent to products actively marketed as demonstrated in Predicate Devices Comparison Chart (see section 4.1)

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around the perimeter of the circle.

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

Hoogland Spine Products GmbH % Spine Now, LLC Ms. Joan L. Carter 94 Gardiners Avenue #307 Levittown, New York 11756

OCT - 9-2009

Re: K083552

Trade/Device Name: maxMorespine Endoscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: October 2, 2009 Received: October 5, 2009

Dear Ms. Carter:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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Page 2 - Ms. Joan L. Carter

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

Sincerely yours.

incerely yours,
for

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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Premarket Notification Submission K083552

K083552

pg 2 ot-<

xMorespine Endoscope

Indications for Use

510(k) Number; K083552

Device Name:

maxMorespine Endoscope

Indications for Use:

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)

Neil RP Ogden for mxm

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

510(k) Number K083552

Page 1 of 1

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.