(100 days)
No
The summary describes a standard electrosurgical device and its generator, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is described as an electrosurgical device intended for procedures like amputation of the uterus and resection of myomas, which are therapeutic interventions.
No
The device description states it is an "electrosurgical device" used for "amputation" and "resection" of tissues, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a "single use disposable high frequency RF bipolar accessory" and a "5mm bipolar electrosurgical device," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the amputation of the uterus and resection of myomas during surgical procedures. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device is a bipolar electrosurgical instrument used in conjunction with a generator. This type of device is used to cut and coagulate tissue during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
Product codes
HIN
Device Description
The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the G400 generator. It is available in an 88mm x 227mm loop size. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus
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
Bench, Biocompatibility, and General Safety Summary:
Design verification testing was carried out to ensure the device meets the product specifications, and design validation was carried out to ensure the product meets the user requirements. All testing was completed successfully. Electrical testing was also carried out to IEC 60601 and passed as well.
In addition the representative final product was tested to and passed ISO-10993-1. The product has been determined to be biocompatible.
Pre-clinical Evaluation Summary:
A pre-clinical evaluation was carried out using extirpated tissue (Human Uterine), and three (3) Physicians. Thirty-two (32) questions were asked of each of the three physicians after they carried out a mock procedure using the proposed device. These questions ranged from ease of understanding the IFU, to performance related questions specific to the procedure. All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and
(iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),”
(2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,”
(3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,”
(4) Labeling:
(i) Indication: For female tubal sterilization, and
(ii) Instructions for use:
(A) Destroy at least 2 centimeters of the fallopian tubes,
(B) Use a cut or undampened sinusoidal waveform,
(C) Use a minimum power of 25 watts, and
(D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.
0
Olympus Surgical Technologies of America · Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
| 510(K) SUMMARY |
|---|
| ---------------- |
PKS" BiLL""
General Information
Manufacturer:
510(k) Submitter:
Contact Person:
Date Prepared:
Classification Name:
Trade Name:
Generic/Common Name:
Bipolar Loop / Bipolar Laparoscopic Loop
Predicate Device
Gyrus ACMI PKS™ BiLLTM
K11059
Indications for Use
The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
Product Description
The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the G400 generator. It is available in an 88mm x 227mm loop size. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10-6.
Page 10
Special 510(k) Notifi
DEC 0 5 2012
Special 510(k) Notification
(508) 804-2690 neil.kelly@Olympus-OSTA.com
Neil Kelly
Gyrus Medical, Ltd. Fortran Road, St. Mellons
Cardiff CF3 OLT ERN: 9617070
Gyrus ACMI Inc. 136 Turnpike Rd.
ERN: 3003790304
Southborough, MA 01772-2104
August 24, 2012
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology HIN 21 CFR 884.4150 Class II
PKSTM BILLTM
BiLap Loop / Bipolar Laparoscopic Loop
1
Olympus Surgical Technologies of America Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Performance Data Technological features and Substantial Equivalence
The PK STM BiLL™ utilizes features incorporated into the following legally marketed predicate device:
- The bipolar PKS™ BiLL™ connects to the same electrosurgical generator, G400 . (K050550) as the predicate PKSTM BiLLTM (K111059).
- The PKSTM BiLL™ uses Bipolar PK (Plasma Kinetic) technology and contains . an identification capacitor embedded in the single use connector cable will be recognized by the generator to set default optimal power output parameters for the subject instrument. This remained unchanged and identical to the predicate PKS™ BiLLTM (K111059).
- . The mechanical design features of the PKS™ BiLL™ are similar to that of the predicate PKSTM BiLLTM (K111059).
The proposed PKS™ BiLL™ has the identical Indications for use as the predicate PKSTM BiLLTM.
The PKS™ BiLLTM instrument is compliant to electrical standards specifically to those applicable sections of IEC 60601 incorporating electrical, thermal safety and Electromagnetic Interference. .
The PKSTM BiLLTM instrument uses materials that are well established and used in other GYRUS ACMI FDA cleared medical devices. Biocompatibility testing on all patient contacting parts has been performed in compliance to the relevant requirements of ISO-10993.
The PKS™ BiLL™ instrument is packaged and sterilized as a sterile single use device.
Bench, Biocompatibility, and General Safety Summary
Design verification testing was carried out to ensure the device meets the product specifications, and design validation was carried out to ensure the product meets the user requirements. All testing was completed successfully. Electrical testing was also carried out to IEC 60601 and passed as well.
In addition the representative final product was tested to and passed ISO-10993-1. The product has been determined to be biocompatible.
Pre-clinical Evaluation Summary
In addition a pre-clinical evaluation was carried out using extirpated tissue (Human Uterine), and three (3) Physicians. Thirty-two (32) questions were asked of each of the three physicians after they carried out a mock procedure using the proposed device. These questions ranged from ease of understanding the IFU, to performance related questions specific to the
2
Olympus Surgical Technologies of Američa Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
procedure. All three physicians were happy with the proposed device and felt it met their needs and performed to their expectations.
ﺎ
Summary
The proposed Gyrus ACMI Inc. Bipolar Laparoscopic Loop (PKS™ BiLL™), as described in this submission, is substantially equivalent to the predicate in intended use, materials, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness.
3
Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person embracing another person.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 5, 2012
Gyrus ACMI, Inc. % Mr. Neil Kelly Regulatory Affairs Specialist 136 Turnpike Road SOUTHBOROUGH MA 01772
Re: K122605
Trade/Device Name: Gyrus ACMI® Bipolar Laparoscopic Loop (PKSTM BILLTM) Regulation Number: 21 CFR§ 884.4150 Regulation Name: Bipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HIN Dated: November 2, 2012 Received: November 5, 2012
Dear Mr. Kelly:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Mr. Neil Kelly
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert R. Lerner
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number:
: K122605
Device Name: Gyrus ACMI® Bipolar Laparoscopic Loop (PKS™ BiLL™)
Indications for Use:
The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
Prescription Use: X
OR Over-the-Counter Use:
(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)
Herbert P. Lerner
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K22605 |