(136 days)
No
The summary describes a standard electrosurgical device and generator, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is used for surgical procedures (amputation/sectioning of the uterus and resection of myomas), which are considered therapeutic interventions.
No
The device is an electrosurgical device used for amputation/sectioning and resection of tissue, which are therapeutic procedures, not diagnostic.
No
The device description clearly states it is a "single use disposable high frequency RF bipolar accessory" and a "laparoscopic instrument," indicating it is a physical hardware device. While it mentions "software selection" in the performance studies, this likely refers to software controlling the associated generator, not the device itself being software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The PKS™ BiLL™ is an electrosurgical device used for the physical cutting and removal of tissue (uterus and myomas) during surgery. It operates directly on the patient's body.
- Intended Use: The intended use clearly states "amputation/sectioning" and "resection," which are surgical procedures, not diagnostic tests performed on samples outside the body.
The device is a surgical instrument used during a procedure, not a test performed on a sample to diagnose something.
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/sectioning 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 (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, devascularized subserosal pedunculated myomas
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)
Preclinical testing has been undertaken to validate the mechanical design, usability considerations and software selection to provide the desired cut and user performance requirements. The performance was compared against the performance characteristics of the predicate LiNA Loop. Bench and preclinical testing demonstrated that the performance requirements were met, and that the PKSTM BiLLTM exhibited comparable performance characteristics to the LiNA Loop.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
PKS™ BiLL™ Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
SEP - 1 2011
Traditional 510(k) Notification
K111059 page 1 of 3
510(k) Summary
General Information
Manufacturer:
Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
Establishment Registration Number:
Contact Person:
Date Prepared:
3003790304
Terrence E. Sullivan Executive Director, Regulatory Affairs
August 31, 2011
Device Description
Classification Name:
Bipolar endoscopic coagulator-cutter and accessories (21 CFR 884.4150), Class II Obstetrics and Gynecology Panel
PKSTM (Plasmakinetic System) BiLLTM
(Bipolar Laparoscopic Loop)
Trade Name:
Generic/Common Name:
BiLap Loop / Bipolar Laparoscopic Loop
Predicate Devices
The predicate devices include: 1. LiNA Loop K070315 2. Gyrus ACMI PlasmaCision Spatula K041633 3. Gyrus ACMI G400 Workstation Generator (and 9-pin PKSTM PlasmaSpatula) K050550
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/sectioning 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.
1
Traditional 510(k) Notification
KIII059 page 2 of 3
Product Description
The Bipolar Laparoscopic Loop (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0
Performance Data, Technological Features and Substantial Equivalence
The PKSTM BiLL™ utilizes features incorporated into the following legally marketed predicate devices:
- The bipolar PKSTM BiLL™ connects to the same electrosurgical generator, . the Gyrus ACMI G400 Workstation Generator (K050550) as the predicate 9-pin PKSTM PlasmaSpatula (K050550).
- The PKSTM BiLL™ uses Bipolar PK technology and contains an � identification capacitor embedded in the single use connector cable, which will be recognized by the generator to set default optimal power output parameters for the subject instrument, as does the PKS™ PlasmaSpatula (K050550)
- The mechanical design features of the PKSTM BiLL™ are similar to that of the predicate LiNA Loop (K070315).
The PKSTM BiLLTM has the same intended use as the predicates PKSTM PlasmaSpatula and LiNA Loop.
The PKS™ BiLL ™ 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 and the LiNA Loop. Full biocompatibility testing on all patient contacting parts has been performed in compliance to the relevant requirements of ISO-10993.
The PKSTM BiLL™ instrument is packaged and sterilized as a sterile single use device and tested to comply with ISO 11607 and ISO11137.
Preclinical testing has been undertaken to validate the mechanical design, usability considerations and software selection to provide the desired cut and user performance requirements. The performance was compared against the performance characteristics of the predicate LiNA Loop. Bench and preclinical testing demonstrated that the
2
Traditional 510(k) Notification
K111059 page 3 of 3
performance requirements were met, and that the PKSTM BiLLTM exhibited comparable performance characteristics to the LiNA Loop.
Summary
The Gyrus ACMI Inc. Bipolar Laparoscopic Loop (PKS™ BiLL™), as described in this submission, is substantially equivalent to the predicates in intended use, materials, principles of operation and fundamental scientific technology and raises no new issues of safety and effectiveness. The evidence included within this submission supports the conclusion that the PKS™ BiLL™ instrument is substantially equivalent to the identified predicates and is safe and effective for its intended purpose.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Terrence E. Sullivan Executive Director. Regulatory Affairs Gyrus ACMI Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772
2011
Re: K111059
Trade/Device Name: PKSTM (Plasmakinetic System) BiLLTM (Bipolar Laparoscopic Loop) instrument Regulation Number: 21 CFR8 884.4150 Regulation Name: Bipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HIN Dated: August 17. 2011 Received: August 18, 2011
Dear Mr. Sullivan:
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 10 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. 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 of medical device-related
4
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
http://www.fda.gov/MedicalDevices/ResourcestoYou/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
5
Traditional 510(k) Notification
PKS™ BiLL™ Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
510(k) Number: K111059
Device Name: Gyrus ACMI® Bipolar Laparoscopic Loop (PKS™ BiLL™)
Statement of Intended 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/sectioning 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:
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)
Heidi Heun
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111059