MAXMORESPINE TOM STICK

K083552 · Hoogland Spine Products, GmbH · HRX · Oct 9, 2009 · Orthopedic

Device Facts

• Record ID: K083552
• Device Name: MAXMORESPINE TOM STICK
• Applicant: Hoogland Spine Products, GmbH
• Product Code: HRX · Orthopedic
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Rigid, multi-channel spinal endoscope; utilizes rod lens optical system for image/light transmission; includes irrigation channels and stopcocks. Constructed of surgical grade stainless steel. Introduced into patient via minimally invasive access through working cannula; compatible with industry-standard endoscopic camera and light systems. Used by surgeons in clinical settings for visualization during spinal procedures. Enables minimally invasive access to surgical site; facilitates diagnostic and therapeutic interventions like discectomy and nucleotomy; benefits patient through reduced invasiveness compared to open surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rigid, multi-channel endoscope; surgical grade stainless steel construction; rod lens optical system; irrigation channels with stopcocks; eyepiece and light post compatible with industry-standard camera/light systems. Sold non-sterile; user-sterilized.

Indications for Use

Indicated for patients requiring visualization of internal anatomy via cannulated incision for diagnostic and surgical spinal procedures including arthroplasty, nucleotomy, discectomy, and foraminotomy.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 [phone] - 20 Phone No.: [phone] - 98 Fax No.:

### USA Agent

Spine Now, LLC 94 Gardiners Ave, #307 Levittown, NY 11756 Phone No .: [phone] [phone] Fax No.:

## Contact Information

Joan L. Carter - President, Spine Now, LLC. Phone No.: [phone] E-mail: [e-mail]

- 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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maxMorespine Endoscope

#### 1.7 Requiatory Class Class II

ﺎ

- 4.8 Classification Product Code HRX
#### 1.9 Intended Use

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.

#### 1.10 Device Description / Technology Characteristics

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).

#### 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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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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

incerely yours,
for

21

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:

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.

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

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