(87 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. The device description is missing, and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The device is used for aspiration of disc material during percutaneous lumbar discectomies, which is an interventional surgical procedure, not a therapeutic treatment itself.
No
The device is described as a "Percutaneous Lumbar Discectomy Probe" intended for "aspiration of disc material during percutaneous lumbar discectomies," which is a surgical procedure, not a diagnostic one.
No
The device is described as a "Percutaneous Lumbar Discectomy Probe," which is a physical instrument used in a surgical procedure. The summary does not mention any software component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration of disc material during a percutaneous lumbar discectomy. This is a surgical procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The Dekompressor™ Percutaneous Lumbar Discectomy Probe is a surgical instrument used in vivo (within the living body), not a test performed in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
The Pain Concepts' Dekompressor™ Percutaneous Lumbar Discectomy Probe is intended for use for the aspiration of disc material during percutaneous lumbar discectomies.
Product codes
HRX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Lumbar
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)
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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
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
Image /page/0/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Russell Pflueger President and CEO Pain Concepts, Inc. 8001 Irvine Center Drive, 4th Floor Irvine, California 92618
Re: K013513
Trade Name: Dekompressorтм Percutaneous Lumbar Discectomy Probe Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: October 19, 2001 Received: October 22, 2001
Dear Mr. Pflueger:
We have reviewed your Section 510(k) premarket 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) 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, 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 (PMA), 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 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); good manufacturing practice requirements as set 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.
1
Page 2 & Mr. Russell Pflueger
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lot 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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» (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INTENDED USE
Page of of of ________________________________________________________________________________________________________________________________________________________________
Kol3513 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Dekompressor™ Percutaneous Lumbar Discectomy Probe
Indications for Use: The Pain Concepts' Dekompressor™ Percutaneous Lumbar Discectomy Probe is intended for use for the aspiration of disc material during percutaneous lumbar discectomies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use ... ... ..
(Per 21 CFR 801.109)
fo Mark N. Millikinn
Division Sign-Off) Division of General, Restorative and Neurological Devices
53 510(k) Nr. -- Lor