(23 days)
The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination with the Smith & Nephew Vulcan EAS Generator, are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and and in coagulating soft tissue in joints including but not limited to the knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a variety of procedures, as listed in the table below.
Examples of Arthroscopic Surgery:
All Joints: Debridement (tendon, cartilage, fracture), Plica Removal, Resection, Synovectomy, Bursectomy, Ablation, Excision of Soft Tissue (scar tissue), Hemostasis of Blood Vessels, Coagulating Soft Tissues (ligament, articular cartilage), and Chondroplasty.
Knee: Meniscectomy, Meniscal Cystectomy, PCL/ACL Debridement, Notchplasty, Lateral Release, Labral Tear.
Shoulder: Acromioplasty, Rotator Cup Debridement, Subacromial Decompression, CA Ligament Resection, and Capsular Release.
Wrist: Triangular Fibrocartilage (TFC).
The Smith & Nephew Saphyre Bipolar Ablation Probes are single-use, bipolar, electrosurgical devices intended for coagulation of soft tissues. The Saphyre Bipolar Ablation Probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Saphyre Bipolar Ablation Probes with Suction incorporate suction capability for the removal of tissue from the surgical site.
The provided text is a 510(k) pre-market notification for the Smith & Nephew Saphyre Bipolar Ablation Probes. It focuses on demonstrating substantial equivalence to predicate devices for modified indications for use, rather than presenting a performance study with acceptance criteria and results for the device itself.
Therefore, most of the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify performance acceptance criteria or report device performance in terms of clinical or technical metrics. The submission is for modified indications for use of an existing device, asserting that "No new risks have been introduced as a result of the modification" and that the "design are equivalent to that of the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Available. No test set or associated data is mentioned, as this is a regulatory submission for modified indications for use, not a performance study that would typically involve a test set.
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/Not Available. Ground truth establishment is not relevant to this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. Adjudication methods are not relevant to this type of submission.
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 ablation probe, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (an electrosurgical probe), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available. Ground truth establishment is not relevant to this type of submission.
8. The sample size for the training set
- Not Applicable/Not Available. The document does not describe a training set as it's not detailing a machine learning model or a performance study with data sets.
9. How the ground truth for the training set was established
- Not Applicable/Not Available. Ground truth establishment for a training set is not relevant to this type of submission.
Summary from the document:
The regulatory submission asserts substantial equivalence based on:
- The modified indications for use and design being equivalent to predicate devices (Vulcan Electrosurgical Probes K000691, ArthroCare ArthroWands K011083, Bipolar Ablation Probes K991218).
- No new risks being introduced due to the modification.
The FDA's review confirms this determination, stating that the device is substantially equivalent for the indications for use provided. This implies that the device, with its modified indications, is considered safe and effective to the same extent as its predicate devices, but this is a regulatory determination of equivalence rather than a report of specific performance metrics against pre-defined acceptance criteria from a clinical study.
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This summary of the 510(k) pre-market notification for the Smith & Nephew Saphyre Bipolar Ablation Probes is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
MAY 2 3 2003
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| Manufacturer | Contact Person(s) |
|---|---|
| Smith & Nephew, Inc | Deborah Connors |
| Endoscopy Division | Smith & Nephew, Regulatory Affairs Manager |
| 3700 Haven Court | 150 Minuteman Road |
| Menlo Park, CA 94025 | Andover, MA 01810 |
Device Name
Saphyre Bipolar Ablation Probes, Class II device (21 CFR 878.4400)
Generic/Common Name
Electrosurgical cutting and coagulation device and accessories
Device Description
The Smith & Nephew Saphyre Bipolar Ablation Probes are single-use, bipolar, electrosurgical devices intended for coagulation of soft tissues. The Saphyre Bipolar Ablation Probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Saphyre Bipolar Ablation Probes with Suction incorporate suction capability for the removal of tissue from the surgical site.
Technological Characteristics
Smith & Nephew is requesting clearance to modify the device's existing general indications for use to more specific indications for use. There was no actual physical change to the device as a result of the proposed modified indications for use statement and, therefore, no changes to the technological characteristics.
Indications for Use
The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination with the Smith & Nephew Vulcan EAS Generator, are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and in coagulating soft tissue in joints including but not limited to the knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a variety of procedures.
Predicate Device(s)
| • Indication for Use: | Vulcan Electrosurgical Probes K000691, cleared May 15, 2000ArthroCare ArthroWands K011083, cleared June 28, 2001 |
|---|---|
| • Design: | Bipolar Ablation Probes K991218, cleared September 13, 1999 |
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Substantial Equivalence Determination
The modified indications for use for the Smith & Nephew Saphyre Bipolar Ablation Probes are substantially equivalent to the predicate devices. This determination is based on the following:
-
I. The indications for use, as modified for the Saphyre Bipolar Ablation Probes, and design are equivalent to that of the predicate devices and;
-
- No new risks have been introduced as a result of the modification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
MAY 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Guthrie Manager Regulatory Affairs and Compliance Smith & Nephew, Inc. Endoscopy Division 3700 Haven Court Menlo Park, California 94025
Re: K031371
Trade/Device Name: Smith & Nephew Saphyre Bipolar Ablation Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 25, 2003 Received: April 30, 2003
Dear Ms. Guthrie:
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.
Image /page/2/Picture/12 description: The image shows a blurry, black and white image of text written in Arabic script. The text appears to be a series of words or phrases repeated multiple times. Due to the blurriness of the image, it is difficult to discern the exact words or meaning of the text.
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Page 2 - Ms. Linda Guthrie
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 (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) you may obtain. 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,
Miriam C. Provost
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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Section 1 - General Information
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K031371 |
|---|---|
| Device Name: | Smith & Nephew Saphyre Bipolar Ablation Probes |
| Indications for Use: | The Smith & Nephew Saphyre Bipolar Ablation Probes, in combinationwith the Smith & Nephew Vulcan EAS Generator, are intended for generalsurgical use, including orthopedic and arthroscopic applications forresection, ablation, excision of soft tissue, hemostasis of blood vessels, andand in coagulating soft tissue in joints including but not limited to theknee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a |
| variety of procedures, as listed in the table below. |
Examples of Arthroscopic Surgery
| All Joints | Debridement (tendon, cartilage, fracture), Plica Removal, Resection, Synovectomy,Bursectomy, Ablation, Excision of Soft Tissue (scar tissue), Hemostasis of BloodVessels, Coagulating Soft Tissues (ligament, articular cartilage), and Chondroplasty. |
|---|---|
| Knee | Meniscectomy, Meniscal Cystectomy, PCL/ACL Debridement, Notchplasty, LateralRelease, Labral Tear. |
| Shoulder | Acromioplasty, Rotator Cup Debridement, Subacromial Decompression, CA LigamentResection, and Capsular Release. |
| Wrist | Triangular Fibrocartilage (TFC). |
Image /page/4/Picture/8 description: The image shows a document with the title "Division Sign-Off" and the text "Division of General, Restorative and Neurological Devices". The document includes the number K031371 and states "PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED". There is a section for "Concurrence of CDRH, Office of Device Evaluation (ODE)" and options for "Prescription Use" and "Over-The-Counter Use", with the former selected.
§ 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.