(186 days)
The Stryker RF Intradiscal Adapter is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Adapter will be used with the previously cleared Stryker Intradiscal RF Generator and catheters such as Smith & Nephew SPINECATH™ & Acutherm™ catheters.
The Stryker RF Intradiscal Adaptor when used with the separately cleared Stryker RF Generator and the separately cleared Smith & Nephew SPINECATHTM Intradiscal Catheter(K993967) and ACUTHERM TM Decompression Catheter or equivalent. The Stryker RF Intradiscal Adaptor is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
The provided text is a 510(k) summary for the Stryker RF Intradiscal Adapter. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, this document does not contain information about clinical studies with acceptance criteria, reported device performance, or details about test datasets, expert involvement, or adjudication methods for AI performance.
Instead, the submission for this device relies on the concept of substantial equivalence to already legally marketed devices. This means that Stryker is asserting that their device is as safe and effective as a previously cleared device, based on similarities in intended use, technological characteristics, and principles of operation, rather than on new clinical performance data from a standalone study.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the provided document does not include such a study.
Here's a breakdown of why the requested information cannot be extracted from this document, specifically addressing each point you asked for:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to predicate devices based on design and intended use, not on quantifiable performance metrics from a dedicated study.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is mentioned, as no new clinical performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring ground truth establishment is detailed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 an adapter for electro-surgical equipment, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is hardware, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
The "Safety and Effectiveness" section explicitly states: "Based upon the comparison to the predicate devices, the Stryker RF Intradiscal Adapter is substantially equivalent to a legally marketed device." This confirms that the approval pathway relies on equivalence, not on new performance data demonstrating the device meets a predefined set of acceptance criteria.
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MAY 2 2 2007
4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com
stryker
Interventional Pain
| 510(k) Summary | |
|---|---|
| Device Sponsor: | Stryker Interventional Pain4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
| Registration No.: | 3005182723 |
| Trade Name: | Stryker RF Intradiscal Adapter |
| Common Name: | Electrosurgical Connecting Cable |
| Classification Name: | Generator, Radiofrequency Lesion (GXD) |
| Equivalent to: | K033981 Smith & Nephew ElectroThermal 20S Spine Generator |
| Device Description: | The Stryker RF Intradiscal Adaptor when used with the separately clearedStryker RF Generator and the separately cleared Smith & NephewSPINECATHTM Intradiscal Catheter(K993967) and ACUTHERM TMDecompression Catheter or equivalent. The Stryker RF Intradiscal Adaptoris intended for the coagulation and decompression of disc material to treatsymptomatic patients with annular disruption of contained herniated discs. |
| Indications for Use: | The Stryker RF Intradiscal Adapter is intended for the coagulation anddecompression of disc material to treat symptomatic patients with annulardisruption of contained herniated discs. The Adapter will be used with thepreviously cleared Stryker Intradiscal RF Generator and catheters such asSmith & Nephew SPINECATHTM & AcuthermTM catheters. |
| Contraindications: | The contraindications for the Stryker RF Intradiscal Adapter would be thesame as those for the catheter to which it is attached. The contraindicationsincluded in the instructions for use for the Smith & NephewSPINECATHTM Intradiscal Catheter and ACUTHERM TM DecompressionCatheter are:Use of the SPINECATHTM Intradiscal Catheter is not appropriate for treatingpatients who present pain that is suspected to originate from structuresother than contained herniated discs, or when free fragments or severe bonystenosis are present. In addition, patients presenting severely degenerativeor disrupted discs should be excluded.andUse of the Decompression Catheter is not appropriate for treating patientswho present pain that is suspected to originate from origins other thanherniated discs, or when free fragments or severe spinal stenosis arepresent. In addition, patients presenting with severely degenerative ordisrupted discs should be excluded.Use of the Smith & Nephew SPINECATHTM Intradiscal Catheter andACUTHERM TM Decompression Catheter is appropriate for treating patients |
| with herniations of intervertebral discs who would typically undergoautomated or laser percutaneous lumbar discectomy.Use of the Smith & Nephew SPINECATH™ Intradiscal Catheter andACUTHERM™ Decompression Catheter is appropriate for treating patientswith herniations of intervertebral discs who would typically undergoautomated or laser percutaneous lumbar discectomy. | |
| Precautions: | Patients taking steroids and patients with pacemakers, lupus, gout,uncontrolled diabetes, Ehlers-Danlos syndrome, prior open capsularprocedures, autoimmune disease, or etiologies where their immune systemsare compromised require special consideration. |
| Substantial Equivalence(SE) Rational: | The Stryker Intradiscal RF Generator has a similar intended use as:Smith & Nephew ElectroThermal 20S Spine Generator (K033981) Smith & Nephew SPINECATH™ catheters (Oratec K993867) Neurotherm NT1000 RF Lesioning System (K052878) Stryker claims this equivalence because the Stryker RF Intradiscal Adapterhas an equivalent intended use, modes of operation, protocols for use, andquality check mechanisms as compared to the predicate devices.Furthermore, the Stryker RF Intradiscal Adapter has equivalent |
| technological characteristics as compared to the predicate devices. | |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker RFIntradiscal Adapter is substantially equivalent to a legally marketed device. |
| Submitted by: | Jean Sheppard |
| Regulatory Analyst | |
| Date submitted: | March 8, 2007 |
KOB34RD
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" written around it. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2007
Stryker Interventional Pain % Ms. Jean Sheppard Regulatory Analyst 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K063480
Trade/Device Name: Stryker RF Intradiscal Adaptor Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GEI Dated: May 10, 2007 Received: May 11, 2007
Dear Ms. Sheppard:
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 he 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 (2) 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. Jean Sheppard
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 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), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ |< 063480
Device Name: Stryker RF Intradiscal Adaptor
Indications for Use:
The Stryker RF Intradiscal Adapter is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Adapter will be used with the previously cleared Stryker Intradiscal RF Generator and catheters such as Smith & Nephew SPINECATH™ & Acutherm™ catheters.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter
(Division Sign-Off) DRE DIRECTOR
Division of General, Re Page 1 of 1 and Neurological Devices
510(k) Number 5/22/10/x
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.