(186 days)
No
The document describes a medical device adapter for use with existing RF generators and catheters. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or other sections.
Yes
The device is intended for "coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs," indicating a direct therapeutic action on the patient's condition.
No
This device is described as being for "coagulation and decompression of disc material to treat symptomatic patients," indicating a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states it is an "Adapter" and is used with a "Generator" and "catheters," all of which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, the Stryker RF Intradiscal Adapter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as an "Adaptor" used with a "Generator" and "catheters" for a therapeutic procedure.
- Anatomical Site: The anatomical site is "Intradiscal," which refers to a location within the patient's body.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The Stryker RF Intradiscal Adapter is used on the human body for treatment.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc material (intervertebral discs)
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.
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
§ 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.
0
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 Pain |
| 4100 E. Milham Avenue | |
| Kalamazoo, 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 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. | |
| 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 SPINECATHTM & AcuthermTM catheters. | |
| Contraindications: | The contraindications for the Stryker RF Intradiscal Adapter would be the |
| same as those for the catheter to which it is attached. The contraindications | |
| included in the instructions for use for the Smith & Nephew | |
| SPINECATHTM Intradiscal Catheter and ACUTHERM TM Decompression | |
| Catheter are: | |
| Use of the SPINECATHTM Intradiscal Catheter is not appropriate for treating | |
| patients who present pain that is suspected to originate from structures | |
| other than contained herniated discs, or when free fragments or severe bony | |
| stenosis are present. In addition, patients presenting severely degenerative | |
| or disrupted discs should be excluded. | |
| and | |
| Use of the Decompression Catheter is not appropriate for treating patients | |
| who present pain that is suspected to originate from origins other than | |
| herniated discs, or when free fragments or severe spinal stenosis are | |
| present. In addition, patients presenting with severely degenerative or | |
| disrupted discs should be excluded. | |
| Use of the Smith & Nephew SPINECATHTM Intradiscal Catheter and | |
| ACUTHERM TM Decompression Catheter is appropriate for treating patients | |
| with herniations of intervertebral discs who would typically undergo | |
| automated or laser percutaneous lumbar discectomy. | |
| Use of the Smith & Nephew SPINECATH™ Intradiscal Catheter and | |
| ACUTHERM™ Decompression Catheter is appropriate for treating patients | |
| with herniations of intervertebral discs who would typically undergo | |
| automated or laser percutaneous lumbar discectomy. | |
| Precautions: | Patients taking steroids and patients with pacemakers, lupus, gout, |
| uncontrolled diabetes, Ehlers-Danlos syndrome, prior open capsular | |
| procedures, autoimmune disease, or etiologies where their immune systems | |
| are 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 Adapter | |
| has an equivalent intended use, modes of operation, protocols for use, and | |
| quality 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 RF |
| Intradiscal 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
4
Indications for Use
510(k) Number (if known): __ |