(63 days)
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.
The BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System is an assortment of surgical instruments utilized in minimally invasive Laparoscopic lumbar discectomy surgical procedures.
This submission (K972768) describes the BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System. This is a premarket notification (510(k)) and centers around demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria through clinical studies.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, and the type of ground truth is not applicable to this 510(k) submission.
The basis for this 510(k) clearance is the substantial equivalence of new disc removal tools and introduction instruments to already legally marketed predicate devices.
Here's why the questions are not applicable based on the provided text:
- No specific acceptance criteria are defined for device performance metrics: The document focuses on the technological and material similarity to predicates, not on quantitative performance targets (e.g., success rates, accuracy, precision, etc.).
- No clinical study is described that proves acceptance criteria are met: The provided text explicitly states: "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." This indicates a comparison to existing devices, not a de novo performance study against defined acceptance criteria.
- No mention of AI/algorithm: This is a surgical instrument system, not an AI or imaging device with algorithms requiring test and training sets, ground truth establishment, or expert reviews.
Table of Acceptance Criteria and Reported Device Performance:
Not applicable, as no specific performance acceptance criteria or performance study results are provided in this 510(k) summary. The demonstration is based on substantial equivalence.
Remaining Points (2-9):
These points are also not applicable as they relate to the methodology of performance studies typically conducted for AI/algorithm-based devices or devices requiring de novo clinical efficacy/effectiveness studies, which is not the case for this 510(k) submission. The submission relies on a comparison to predicate devices, not on a new clinical study with the described elements.
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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
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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(Per 21 CFR 801.109) | Or Over-the-Counter Use |
| (Optional Format 1-2-96) |
§ 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.