(23 days)
Not Found
No
The document describes a standard electrosurgical device for tissue ablation and coagulation and does not mention any AI or ML capabilities.
Yes
The device is used for surgical procedures such as resection, ablation, excision of soft tissue, and hemostasis of blood vessels, which are considered therapeutic interventions.
No
The device is described as an electrosurgical device for resection, ablation, excision, hemostasis, and coagulation of soft tissue in joints, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it consists of physical components like an insulated shaft, electrodes, and a handle, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "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". This describes a device used during a surgical procedure on a patient's body.
- Device Description: The description details a "bipolar, electrosurgical device" used for "coagulation of soft tissues". This is consistent with a surgical tool, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions by examining these types of samples.
Therefore, the Smith & Nephew Saphyre Bipolar Ablation Probes are surgical devices used for treatment and manipulation of tissue within the body, not for in vitro diagnostic testing.
N/A
Intended Use / 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 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 Quarter
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).
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joints including but not limited to the knee, shoulder, wrist, hip
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
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
1872
| 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, 2000
ArthroCare ArthroWands K011083, cleared June 28, 2001 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|
| • Design: | Bipolar Ablation Probes K991218, cleared September 13, 1999 |
1
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.
2
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.
3
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
4
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 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). |
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.