(33 days)
Not Found
No
The description focuses on standard electrosurgical instruments and their function, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
No
The device is described as facilitating grasping, cutting, and manipulation of soft tissue and blood vessels, which are surgical functions, not therapeutic ones. The use of high-frequency electrical current is for electrocautery (cutting/coagulation), not therapy.
No
This device is for surgical manipulation (grasping, cutting, and electrocautery) of tissue during laparoscopic procedures, not for identifying a medical condition or disease.
No
The device description explicitly states it is comprised of "non-sterile, reusable endoscopic scissors and forceps," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instruments are for "facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery)." This describes a surgical tool used on the patient's body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description details reusable endoscopic scissors and forceps that utilize electrical energy. This aligns with surgical instruments, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Sovereign Bipolar Instruments are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Aesculap's Sovereign Bipolar Instruments are comprised of a variety of non-sterile, reusable endoscopic scissors and forceps. The modular instruments utilize standard bipolar cables (with flat plugs) connected to compatible electrosurgical generators that supply bipolar energy. The instruments may be sterilized by steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and blood vessels
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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The Sovereign Bipolar Instruments, however, conform to the following electromedical standard: IEC 60601-2-18.
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
SOVEREIGN™ BIPOLAR INSTRUMENTS
MAY 3 0 2000
Page 1 of 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
SOVEREIGN™ BIPOLAR INSTRUMENTS
April 26, 2000
- Aesculap®, Inc. COMPANY: 1000 Gateway Blvd. So. San Francisco, CA 94080
- CONTACT: Lia S. Jones, Regulatory Associate 650-624-5073 (phone) 650-589-3007 (fax) lia.jones@aesculap.com (email)
- TRADE NAME: SOVEREIGN™ Bipolar Instruments
- COMMON NAME: Bipolar Instrument
DEVICE CLASS: Class II
- PRODUCT CODE: GEI
- CLASSIFICATION: 878.4400
- Electrosurgical cutting and coagulation device and accessories
- General & Plastic Surgery REVIEW PANEL:
INTENDED USE
The Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).
DEVICE DESCRIPTION g
Aesculap's Sovereign Bipolar Instruments are comprised of a variety of non-sterile, reusable endoscopic scissors and forceps. The modular instruments utilize standard bipolar cables (with flat plugs) connected to compatible electrosurgical generators that supply bipolar energy. The instruments may be sterilized by steam sterilization.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The Sovereign Bipolar Instruments, however, conform to the following electromedical standard: IEC 60601-2-18.
SUBSTANTIAL EQUIVALENCE
The Sovereign Bipolar Instruments are substantially equivalent in their intended use, material composition, labeling, design and basic operating principles to the following predicate devices:
- Aesculap Bipolar Forceps (K954652) .
- Jarit Detach® Bipolar System ●
- Enable Endoscopic Bipolar Scissors (K992996) .
- · Valleylab BiSure™ Laparoscopic Bipolar Forceps (K983743)
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol consisting of three stylized human profiles facing right, with flowing lines beneath them.
MAY 3 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lia S. Jones Regulatory Associate Aesculap, Inc. 1000 Gateway Boulevard South San Francisco. California 94080-7028
K001330 Re: Trade Name: SOVEREIGN Bipolar Instruments Regulatory Class: II Product Code: GEI Dated: April 26, 2000 Received: April 27, 2000
Dear Ms. Jones:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 device in the Federal Register. Please note: this response to your premarket notification submission 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.
2
Page 2 - Ms. Lia S. Jones
This letter will allow you to begin marketing your device as described in your 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 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 your device, 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 yours,
Dune R. Lochner.
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
3
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K00133 0
SOVEREIGN™ Bipolar Instruments Device Name:
Indication for Use:
The Sovereign Bipolar Instruments are intended to facilitate grasping, cutting and manipulation of soft tissue and blood vessels during laparoscopic procedures with the use of high-frequency electrical current (bipolar electrocautery).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Danne R. be Ams.
(Division Sign-Off) Division of General Restorative Devices 10(k) Number KOQ133 C
Prescription Use
(per 21 CFR 801.109)
or Over-the-Counter Use
(Optional Format 3-10-98)