(71 days)
The Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator.
The Stryker Silverglide Bipolar Forceps Reusable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Reusable Cable is supplied non-sterile. It must be steam sterilized before use.
The Stryker Silverglide Bipolar Forceps Disposable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Disposable Cables is supplied sterile, and is a single-patient use device.
Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the Stryker Silverglide Bipolar Forceps Cables:
This document is a 510(k) summary for a medical device. In the context of 510(k) submissions, the "acceptance criteria" and "study" are typically focused on demonstrating substantial equivalence to a predicate device, rather than proving a specific performance metric against a predefined numerical acceptance criterion. The "study" largely consists of a comparison and justification of equivalence to existing devices.
Therefore, many of the requested fields related to a traditional performance study (e.g., sample size, number of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, ground truth establishment for training sets) are not applicable in this type of submission. The focus is on design, materials, indications for use, and technological characteristics being sufficiently similar to a legally marketed predicate.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use: Must be the same or similar to predicate devices. | "The Stryker Silverglide Bipolar Forceps Reusable Cable and the Stryker Silverglide Bipolar Forceps Disposable Cable have the same intended use as the Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cable and the Modern Medical Equipment Mfg. Ltd. Disposable Bipolar Forceps Cable." |
| Technological Characteristics: Must be sufficiently similar to predicate devices. | ". . . the same technological characteristics, the same operating principles and have similar performance characteristics." |
| Safety and Effectiveness: Must be deemed as safe and effective as predicate devices. | "Based upon the comparison to the predicate devices, the Stryker Silverglide Bipolar Forceps Reusable Cable and the Stryker Silverglide Bipolar Forceps Disposable Cable are substantially equivalent to legally marketed devices." |
Detailed breakdown of other requested information:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This is a 510(k) submission seeking substantial equivalence based on comparison to predicate devices, not a clinical performance study with a test set of data. The "test" is an analytical comparison of device features and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. No ground truth for a test set was established in the traditional sense. The "ground truth" for substantial equivalence is the regulatory status and characteristics of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication process as described.
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 cable for electrosurgical forceps, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (cable), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the established regulatory clearance and performance characteristics of the predicate devices. The new device's characteristics (intended use, technological characteristics, operating principles, and performance characteristics) are compared to these existing, legally marketed devices.
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. Not an AI/ML device.
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SEP - 8 2006
Page 1 of 2 stryker®
4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com
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Instruments
| K061835 | |
|---|---|
| 510(k) Summary | |
| Device Sponsor: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
| Registration No.: | 1811755 |
| Trade Name: | Stryker Silverglide Bipolar Forceps Reusable CableStryker Silverglide Bipolar Forceps Disposable Cable |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Name: | Bipolar Forceps Cable |
| Equivalent to: | K042608 Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps CableK023996 Modern Medical Equipment Mfg. Ltd. Disposable Bipolar Forceps Cable |
| Device Description: | The Stryker Silverglide Bipolar Forceps Reusable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Reusable Cable is supplied non-sterile. It must be steam sterilized before use.The Stryker Silverglide Bipolar Forceps Disposable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Disposable Cables is supplied sterile, and is a single-patient use device. |
| Indications for Use: | The Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. |
| Contraindications: | None |
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| Substantial Equivalence | 061835 |
|---|---|
| (SE) Rational: | The Stryker Silverglide Bipolar Forceps Reusable Cable and the StrykerSilverglide Bipolar Forceps Disposable Cable have the same intended useas the Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cableand the Modern Medical Equipment Mfg. Ltd. Disposable BipolarForceps Cable. This device and the predicate device have the sametechnological characteristics, the same operating principles and have similarperformance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker SilverglideBipolar Forceps Reusable Cable and the Stryker Silverglide Bipolar ForcepsDisposable Cable are substantially equivalent to legally marketed devices. |
| Submitted by: | Jean Sheppard |
| Regulatory Analyst | |
| Signature | |
| Date submitted: |
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SEP - 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Instruments % Ms. Jean W. Sheppard Regulatory Analyst 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K061835
Trade/Device Name: Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Biopolar forceps Disposable Cable Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 28, 2006 Received: June 29, 2006
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, Insting 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
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Page 2 - Ms. Jean W. Sheppard
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.
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 your
f-R Ralle
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 Statement
510(K) Number (if known): __ KO 6 1 8 35 Stryker Silverglide Bipolar Forceps Reusable Cable and Device Name: Stryker Silverglide Bipolar Forceps Disposable Cable Indications for Use: The Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. Prescription Use Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ or (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ct. 22
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number: `K061835
§ 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.