(65 days)
Not Found
Not Found
No
The document describes a standard surgical instrument (bipolar scissors) and its intended use for cutting and coagulation. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies described are standard preclinical and clinical evaluations for a surgical device.
No
The device is a surgical instrument used to cut and coagulate tissue during open surgical procedures, which is an intervention, not a therapeutic treatment itself.
No
The device is described as a surgical instrument (scissors) used for cutting and coagulating tissue during open surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical instrument (scissors) used in surgical procedures, not a software application.
Based on the provided information, the PowerStar Bipolar Scissors are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "cut and coagulate soft tissue in open surgical procedures." This describes a surgical instrument used directly on a patient's tissue during surgery.
- Device Description: The description reinforces that it's a "reusable instrument available in various standard sizes and shapes similar to conventional surgical scissors" and is used to "facilitate dissection, transection, and bipolar coagulation." This is consistent with a surgical tool.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The PowerStar Bipolar Scissors do not perform this function. They are used in vivo (within the living body) during a surgical procedure.
Therefore, the PowerStar Bipolar Scissors are a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.
"The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries".
Surgical procedures would include the following:
General Surgery Bowel Breast Biopsies Hernia Repair Lysis of Adhesions Upper GI GI (other) Cholecystectomy Thyroid Splenectomy
OB/GYN Surgery Hysterectomy Salpingo-oophrectomy Mvomectomy Endometriosis Ovariohysterectomy
Oncological Surgery Mastectomy Axillary Node Dissection
Plastic Surgery Mammoplasty Blepharoplasty Rhytidectomy Panniculectomy Forearm Pedicle Flap Facial
Nephrectomy Prostatectomy Cystotomy
Ear, Nose & Throat Surgery Neck Mass Mastoidectomy
Typanoplasty Tonsillectomy Cardiovascular/Thoracic Surgery Femoral Popliteal Bypass Internal Mammary Artery (IMA) Harvesting Pericardial Window Biopsy of the Thymus
Product codes
GEI
Device Description
The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Soft tissue
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended.
Sufficient data has been gathered from pre-clinical and clinical testing to assess the safety and effectiveness characteristics of the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2 9 1997
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Safety and Effectiveness Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
MODIFIED DEVICE NAME: PowerStar Bipolar Scissors
EXISTING (legally marketed) DEVICE NAME: PowerStar Bipolar Scissors
510(K) SUMMARY
Device Description
The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.
Intended Use
The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.
Continued on next page
PowerStar Bipolar Scissors ETHICON, Inc.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
device.
Indications Statement
Technological Characteristics
Performance Data
Conclusions
Contact
Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended.
The modified device is technologically the same as the existing
The PowerStar Bipolar Scissors are non-sterile, reusable devices
tissue in open surgical procedures such as general, gynecological,
intended to facilitate cutting and bipolar coagulation of soft
oncologic, vascular, plastic, thoracic, ear, nose and throat,
urological, and cardiovascular surgeries.
Sufficient data has been gathered from pre-clinical and clinical testing to assess the safety and effectiveness characteristics of the modified device.
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.
Gregory R. Jones Director Regulatory Affairs ETHICON, Inc. Rt. #22 West Somerville, NJ 08876-0151
and the same of the same of the same of the same of
Date
PowerStar Bipolar Scissors ETHICON, Inc.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gregory R. Jones Director Regulatory Affairs Ethicon, Inc. PO Box 151 Somerville, New Jersey 08876-0151
OCT 2 9 1997
K973173 Re:
Trade Name: PowerStar Bipolar Scissors and Accessories Regulatory Class: II Product Code: GEI Dated: August 20, 1997 Received: August 25, 1997
Dear Mr. Jones:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions
3
Page 2 - Mr. Gregory R. Jones
does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of vour devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
to collyp
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
Indications for Use:
PowerStar Bipolar Scissors
"The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries".
Surgical procedures would include the following:
General Surgery Bowel Breast Biopsies Hernia Repair Lysis of Adhesions Upper GI GI (other) Cholecystectomy Thyroid Splenectomy
OB/GYN Surgery Hysterectomy Salpingo-oophrectomy Mvomectomy Endometriosis Ovariohysterectomy
Oncological Surgery Mastectomy Axillary Node Dissection
Plastic Surgery Mammoplasty Blepharoplasty Rhytidectomy Panniculectomy Forearm Pedicle Flap Facial
Nephrectomy Prostatectomy Cystotomy
Ear, Nose & Throat Surgery Neck Mass Mastoidectomy
Typanoplasty Tonsillectomy Cardiovascular/Thoracic Surgery Femoral Popliteal Bypass Internal Mammary Artery (IMA) Harvesting Pericardial Window Biopsy of the Thymus
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The Counter Use |
| (Optional Format 1-2-9G) | ||
| (Division Sign-Off) | ||
| PowerStar Bipolar. Scissors | ||
| ETHICON, Inc. | Division of General Restorative Devices | |
| 510(k) Number | K973173 | |
| iii |
e Flap
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Urological Surgery
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