BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM

K972768 · Blackstone Medical, Inc. · HRX · Sep 25, 1997 · Orthopedic

Device Facts

• Record ID: K972768
• Device Name: BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BLACKSTONE MEDICAL INC. Laparoscopic Disc Removal System is to be used in the anterior Laparoscopic decompression of the intervertebral disc in the lumbar region of the spine.

Device Story

System consists of surgical instruments for minimally invasive laparoscopic lumbar discectomy. Used by surgeons in an operating room setting to perform anterior decompression of lumbar intervertebral discs. Instruments facilitate physical removal of disc material. Output is the mechanical excision of herniated tissue, enabling decompression of spinal nerves. Benefits include minimally invasive access to the lumbar spine for patients unresponsive to conservative therapy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and material comparison to predicate devices.

Technological Characteristics

Assortment of surgical instruments for laparoscopic lumbar discectomy. Materials and technology are stated to be equivalent to predicate systems. No electronic, software, or energy-based components described.

Indications for Use

Indicated for patients with lumbar intervertebral disc herniation presenting with unilateral leg pain exceeding back pain, paresthetic discomfort in a specific dermatomal distribution, positive straight leg raising test or bowstring sign, and potential neurological findings (wasting, weakness, sensory/reflex alteration). Indicated for patients failing at least six weeks of conservative therapy with positive CT or MRI confirming subligamentous herniation consistent with clinical findings.

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

• Surgical Dynamics, Inc. Working Channel Scope and Instrument Set
• Blackstone Medical Inc. Nucleus Pulposus Evacuator System

Submission Summary (Full Text)

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SEP 25

BLACKSTONE MEDICAL, INC. 90 Brookdale Drive Springfield, MA 01104

Premarket Notification BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System Confidential

K972768

## 510 (k) Summary BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k), Premarket Notification, was in accordance with 21 CFR 807.87.

The BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System is an assortment of surgical instruments utilized in minimally invasive Laparoscopic lumbar discectomy surgical procedures.

The conclusion that the BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System is substantially equivalent to legally marketed predicate systems was reached through consideration of the requirements of substantial equivalence determinations. These requirements are set forth in the document, published on June 30, 1986 by the Center for Devices and Radiological Health (CDRH), entitled "Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program."

The new disc removal tools and introduction instruments contain substantially equivalent technology and materials as the predicate disc removal tools utilized in both the Surgical Dynamics, Inc. Working Channel Scope and Instrument Set, and the Blackstone Medical Inc. Nucleus Pulposus Evacuator System.

Based on the reasons provided, the BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System is substantially equivalent to legally marketed predicate minimally invasive Laparoscopic lumbar discectomy surgical instruments.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.

SEP 2 5 997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Joseph S. Mooney .Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K972768

> Trade Name: BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System Regulatory Class: II Product Code: HRX Dated: July 22, 1997 Received: July 24, 1997

Dear Mr. Mooney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Mr. Joseph S. Mooney

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

sincerely yours,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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BLACKSTONE MEDICAL, INC. 90 Brookdale Drive Springfield, MA 01104

Premarket Notification BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System Confidential

# 510(k) Number (if known):

Device Name: Laparoscopic Disc Removal System

#### Intended Use/Indications:

The BLACKSTONE MEDICAL INC. Laparoscopic Disc Removal System is to be used in the anterior Laparoscopic decompression of the intervertebral disc in the lumbar region of the spine.

Unilateral leg pain greater than back pain. Paresthetic discomfort in a specific dermatomal distribution. Positive straight leg raising test and/or positive bowstring sign. Patient demonstrates possible neurological findings (wasting, weakness, sensory alteration, and reflex alteration). Patient shows no improvement after at least six weeks of conservative therapy. A positive CT or MRI that shows a subligamentous herniation at the location consistent

with clinical findings.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K972768 |
| Prescription Use<br>(Per 21 CFR 801.109) | Or Over-the-Counter Use |
| | (Optional Format 1-2-96) |