(63 days)
Not Found
Not Found
No
The 510(k) summary describes a set of surgical instruments for a laparoscopic procedure and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is described as an assortment of surgical instruments used for disc removal, which is a surgical procedure rather than a therapeutic treatment in itself. Its purpose is to remove the disc, relieving pressure on the nerves, but it does not directly provide therapy.
No
The device is described as an assortment of surgical instruments used for procedures, specifically "Laparoscopic decompression of the intervertebral disc". Its intended use lists clinical findings and imaging results (CT or MRI) that lead to its use, but it does not perform any diagnostic function itself.
No
The device description explicitly states it is an "assortment of surgical instruments," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The BLACKSTONE MEDICAL INC. Laparoscopic Disc Removal System is a set of surgical instruments used for a surgical procedure (laparoscopic decompression of the intervertebral disc). It is used on the patient's body during surgery, not to analyze samples taken from the body.
- Intended Use: The intended use describes a surgical procedure to treat a specific condition based on clinical findings and imaging results. It does not involve analyzing biological samples.
Therefore, this device falls under the category of a surgical instrument or system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The BLACKSTONE MEDICAL, INC. Laparoscopic Disc Removal System is an assortment of surgical instruments utilized in minimally invasive Laparoscopic lumbar discectomy surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar region of the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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
3
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) |