(74 days)
No
The description focuses on the mechanical and electrical aspects of a surgical loop and its compatibility with an electrosurgical generator, with no mention of AI or ML.
Yes
The device is described as an electrosurgical device used for the amputation of the uterus and resection of myomas, which are direct interventions aimed at treating a medical condition.
No
The device is an electrosurgical device specifically used for amputation and resection of tissue, not for diagnosing conditions.
No
The device description clearly states it is a "single use disposable high frequency RF bipolar accessory" and mentions physical characteristics like size and sterilization method, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the "amputation of the mobilised uterus" and "resection of devascularized subserosal pedunculated myomas" during surgical procedures. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description confirms it's a "bipolar electrosurgical device" used in conjunction with an electrosurgical generator. This is a surgical tool.
- Anatomical Site: The specified anatomical sites (Uterus, subserosal pedunculated myomas) are within the human body.
- Performance Studies: The performance studies focus on mechanical and tissue tests, electrical safety, biocompatibility, and sterilization – all relevant to a surgical device used on a patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Bipolar Laparoscopic Loop 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 Olympus Electrosurgical Generator ESG-400.
Product codes (comma separated list FDA assigned to the subject device)
HIN
Device Description
The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Olympus Electrosurgical Generator ESG-400. It is available in an 88mm x 227mm loop size. The device is sterilized by ethylene.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data were created to demonstrate substantial equivalence with the predicate device PKS Bill.
The verification and validation activities involved mechanical and tissue tests as well as electrical safety, biocompatibility and sterilization testing according to FDA recognized standards.
Interface tests to demonstrate compatibility to the Electro Surgical Generator ESG-400 were performed during this submission.
The technical justification report comprises the device requirements not needing additional tests to demonstrate substantial equivalence and can be adopted from predicate device.
The Lap Loop is compliant to electrical standards specifically to those applicable sections of IEC 60601-1:2005/(R)2012 and 60601-2-2:2009 Edition 5.0 incorporating electrical, thermal safety and Electromagnetic Interference.
Biocompatibility testing was completed on the predicate PKS BiLL and therefore is used to leverage the PK Lap Loop device given the commonality of patient contact parts. As an additional measure, Cytotoxicity tests on all patient contacting parts have been performed in compliance to the relevant requirements of ISO 10993:2009.
It is packaged and sterilized as a sterile single use device tested according to FDA recognized consensus standards ISO 11607 (11607-1:2006/(R)2010 and 11607-2:2006 First edition) and 11737 (11737-1:2006 Second Edition and 11737-2:2009 Second Edition).
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.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2014
Olympus Winter & Ibe GmbH % Graham Baillie Regulatory Affairs Olympus Surgical Tech. America 136 Turnpike Road Southborough, MA 01772
Re: K142525
Trade/Device Name: PK Lap Loop Regulation Number: 21 CFR 884.4150 Regulation Name: Bipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: Class II Product Code: HIN Dated: September 5, 2014 Received: September 10, 2014
Dear Graham Baillie,
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. 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
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Benjamin R. Fisher -A
Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name PK Lap Loop
Indications for Use (Describe)
The Bipolar Laparoscopic Loop 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 Olympus Electrosurgical Generator ESG-400.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Traditional 510(k) Notification August 29th, 2014
PK Lap Loop
510(k) Premarket Notification
510(k) Summary
Olympus Winter & Ibe
4
Bipolar Laparoscopic Loop PK Lap Loop Olympus Winter & Ibe
Traditional 510(k) Notification August 29th, 2014
510(k) Summary of Safety and Effectiveness
General information
| Applicant: | Olympus Winter & Ibe GmbH
Kuehnstrasse 61
22045 Hamburg
Germany |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 9610773 |
| Manufacturer: | Olympus Winter & Ibe GmbH
Kuehnstrasse 61
22045 Hamburg
Germany |
| 510(k) Submitter: | Gyrus ACMI, Inc.
Olympus surgical Technologies America (OSTA)
136 Turnpike Road
Southborough, MA 01772
Phone (508) 804-2738
Fax (508) 804-2624
Establishment Registration No. 3003790304 |
| Official Correspondent: | Graham Baillie
Regulatory Affairs Manager
Phone: 508.804.2738
Fax: 508.804.2624
Email: Graham.baillie@olympus-osta.com |
| Contact person: | Mr. Holger Nadler
Phone: +49-66966-2860
Fax:
+49-66966-2134
Email: holger.nadler@olympus-oste.eu |
| Date Prepared: | August 29th, 2014 |
| Trade Name: | Pk Lap Loop |
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Device identification
| Proprietary name: | PK Lap Loop |
|---|---|
| Device Classification name: | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) |
| Regulation Medical Specialty: | Obstetrics/Gynecology |
| Regulations Number: | 21 CFR 884.4150 |
| Regulatory class: | Class II |
| Product code: | HIN |
Predicate device
K122605: PKS BILL
Description of device
The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Olympus Electrosurgical Generator ESG-400. It is available in an 88mm x 227mm loop size. The device is sterilized by ethylene.
Intended use
The bipolar Laparoscopic Loop 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 Olympus Electrosurgical Generator ESG-400.
Comparison of the technology between the PK Lap Loop and PKS BiLL
The technical characteristics are listed below
| Compatibility | ||
|---|---|---|
| Electrosurgical | ||
| Generator | For PK Lap Loop the RF is delivered through the Olympus | |
| ESG 400 generator and the PKS BILL energy is delivered | ||
| through the Gyrus G400 | different | |
| Energy used and | ||
| delivered | Identical output waveforms and power levels are used in | |
| both devices. | identical | |
| Compatibility with | ||
| other | ||
| devices | Same as PKS Bill. Device not to be activated at the same | |
| time as other electrosurgical devices. | identical | |
| Design | ||
| Design | The design of the PK Lap Loop device is fundamentally | |
| the same as PKS BILL. There are minor changes that have | ||
| no impact upon safety, usability and performance. | similar | |
| Performance | The performance of the PK Lap Loop device in use with | |
| the ESG400 generator is the same as PKS BILL in use with | ||
| the Gyrus G400 generator. This considers tissue effect, | ||
| speeds and forces required to complete the amputation. | identical | |
| Device Minimum and | ||
| Maximum output | ||
| powers | Average power of one cycle period is 200W. | identical |
| Cutting time |