(87 days)
The Dekompressor™ Percutaneous Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.
The Dekompressor™ is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus.
The provided text is a 510(k) summary for the Stryker Dekompressor™ Percutaneous Discectomy Probe, and as such, it does not contain a detailed study report with acceptance criteria and device performance results. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data with specific performance metrics against acceptance criteria.
Therefore, most of the requested information cannot be extracted directly from this document. The document focuses on:
- Device Description and Intended Use: The Dekompressor™ is a single-use disposable probe for aspirating disc material in percutaneous discectomies of the lumbar, thoracic, and cervical spine.
- Technological Comparison: The device is stated to have the same technology as the Stryker Dekompressor™ Lumbar Discectomy Probe (K013513) and is equivalent to several other predicate devices. This implies that its safety and effectiveness are established through comparison to devices already on the market, rather than through independent studies with new acceptance criteria.
- Regulatory Classification: Classified as an Arthroscope and accessories (21 CFR 888.1100, Class II).
- FDA Clearance: The letter confirms FDA's determination of substantial equivalence (K032473) to legally marketed predicate devices.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
Stryker Dekompressor™ Percutaneous Discectomy Probe (K032473)
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria or quantitative device performance metrics (e.g., success rates, aspiration volume, tissue removal efficiency) against such criteria are provided in this 510(k) summary. The submission relies on establishing substantial equivalence to predicate devices, implying that the performance is considered acceptable if it is comparable to that of the already cleared predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. Substantial equivalence claims often rely on bench testing, design comparisons, and sometimes non-clinical data rather than large-scale human clinical trials with defined test sets in the context of performance metrics.
- Data Provenance: Not specified. Given the nature of a 510(k) for substantial equivalence, the "data" would primarily be engineering specifications, material properties, and comparison to predicate devices, rather than data from a clinical "test set" in the traditional sense for evaluating new performance against set criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable or not specified. "Ground truth" in the context of performance criteria for diagnostic accuracy or treatment efficacy is not presented here. The evaluation is based on technical and functional equivalence to predicate devices.
4. Adjudication method for the test set:
Not applicable or not specified for performance against acceptance criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (surgical probe), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of performance against acceptance criteria for a new device study. The "ground truth" for a 510(k) like this centres on proving that the new device is as safe and effective as a legally marketed predicate device, often through engineering and functional comparisons.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
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K032473 ($\rho_j$ 1-fi)
NOV - 7 2003
stryker
510(k) Summary
4100 East Milham Avenue
Kalamazoo, MI 49001
Phone (269) 323-7700
(800) 253-3210
| Trade Name: | Stryker Dekompressor™ Percutaneous Discectomy Probe |
|---|---|
| Common Name: | Percutaneous Discectomy Probe |
| Classification Name: | Arthroscope and Accessories, 21 CFR 888.1100 (a) |
| Equivalent to: | Stryker Dekompressor™ Lumbar Discectomy Probe (K013513),Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator(K844131, K902778, K914282, K913145, K923525, K931109,K942987), Arthrocare Perc-D™ Spinewand™ family (K010811) |
| Device Description: | The Dekompressor™ is a single use disposable discectomy probethat passes through and works in conjunction with an introducercannula to remove intervertebral disc nucleus pulposus. |
| Intended Use: | The Dekompressor™ Percutaneous Discectomy Probe is intendedfor use in aspiration of disc material during percutaneousdiscectomies in the lumbar, thoracic and cervical regions of thespine. |
| TechnologicalComparison: | The Stryker Dekompressor™ Percutaneous Discectomy Probehas the same technology as the Stryker Dekompressor™ LumbarDiscectomy Probe. |
| Submitted by: | Dannielle C. WheelerRegulatory Affairs RepresentativeStryker Instruments |
| Signature Date | |
| Date Submitted: | August 11, 2003 |
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2003
Ms. Robin L. Rowe Regulatory Affairs Associate Manager Stryker Instruments 4100t Milham Avenue Kalamazoo, Michigan 49001
Re: K032473
Trade/Device Name: Stryker Dekompressor™ Percutaneous Discectomy Probe Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: August 7, 2003 Received: August 12, 2003
Dear Ms. Rowe:
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, 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.
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Page 2 - Ms. Robin L. Rowe
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of vour 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). please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark N. Millikin
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
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Page_ 1_ of __ 1
510(k) Number:
Device Name:
Stryker Dekompressor™ Percutaneous Discectomy Probe
Indications For Use:
The Dekompressor™ Percutaneous Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The- Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark N Milkerson
(Division Sign-off)
Division of General, Restorative and Neurological Devices
510(k) Number KD 32473
§ 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.