(116 days)
HF cable for electrotherapeutical use in endoscopic procedures in conjunction with compatible active accessories and compatible electrosurgical units.
The Olympus monopolar single-use HF cable that is subject to this submission connects a compatible electrosurgical generator with the working element of a resectoscope for the application of monopolar HF current during endoscopic procedures.
The HF cable is delivered in sterile condition and is intended for single use only.
The monopolar single-use HF cable consists of a proximal plug connecting to the HF generator, an insulated cord and a distal plug connecting to the working element of the resectoscope.
The provided text describes a 510(k) premarket notification for a Monopolar Single-use HF Cable. This document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.
However, based on the information provided, I can extract the closest parallels to your request:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted to demonstrate safety and effectiveness. These tests implicitly serve as acceptance criteria, meaning the device had to pass these tests to be considered substantially equivalent. The "reported device performance" is essentially that the device passed all these tests, thereby meeting the implied acceptance criteria. Specific quantitative results are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with Electrical Safety standards (AAMI/ANSI ES 60601-1, IEC 60601-2-2, IEC 60601-2-18) | Device passed tests for electrical safety and general requirements |
| Compliance with Electromagnetic Compatibility (EMC) standards (IEC 60601-1-2) | Device passed tests for electromagnetic compatibility |
| Successful Insertion & Retraction Force tests of connectors | Tests conducted; presumably passed (no issues reported) |
| Successful Cable marking durability test | Test conducted; presumably passed (no issues reported) |
| Successful Surface temperature measurement test | Test conducted; presumably passed (no issues reported) |
| Successful Cable insulation HF and Mains Dielectric Strength test | Test conducted; presumably passed (no issues reported) |
| Successful Cable anchorage test | Test conducted; presumably passed (no issues reported) |
| Successful Fluid ingress test | Test conducted; presumably passed (no issues reported) |
| Successful Continuity test | Test conducted; presumably passed (no issues reported) |
| Successful Cable tensile strength test | Test conducted; presumably passed (no issues reported) |
| Successful Connector grip test | Test conducted; presumably passed (no issues reported) |
| Successful Output power measurement | Test conducted; presumably passed (no issues reported) |
| Successful Transport testing | Test conducted; presumably passed (no issues reported) |
| Sterility Assurance Level (SAL) of 10^-6 | Achieved 10^-6 SAL through EtO sterilization validation |
| EtO residuals within limits | EtO residuals found within limits after tunnel degassing |
| Shelf Life of 1 year | Shelf life testing supports a shelf life of 1 year |
| Durability of materials | Durability of new materials has been tested successfully |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the individual performance tests. It mentions "Conducting tests included the following tests," implying that the device (or samples of the device) underwent these tests. The provenance of the data is from Germany (Olympus Winter & Ibe GmbH, Hamburg, Germany) where the manufacturer is located and presumably where the tests were performed. The nature of these tests (e.g., electrical, mechanical, sterilization) is typically prospective testing of manufactured devices or prototypes, rather than retrospective data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to the described device and study. The "ground truth" for this medical device (a cable) is established through engineering and laboratory performance testing against recognized standards, not through expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no human interpretation or adjudication of outputs in the context of these device performance tests. The tests are objective measurements against predefined engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is an HF cable, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical accessory (a cable), not an algorithm. Standalone performance testing refers to the device's ability to meet its specifications independently, which is what the listed performance tests generally evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is derived from international and national recognized standards for medical electrical equipment (e.g., AAMI/ANSI ES 60601-1, IEC 60601-2-2, IEC 60601-1-2) and specific ISO standards for sterilization and packaging (ISO 11135, AAMI ANSI ISO 11607-1:2006). This includes objective measurements of electrical safety, mechanical durability, and sterilization effectiveness against predefined limits set by these standards.
8. The sample size for the training set
This is not applicable. The device is a physical medical accessory, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
Olympus Winter & Ibe GmbH % Mr. Graham Baillie Manager, Regulatory Affairs Gyrus ACMI, Inc. 136 Turnpike Road Southborough, Massachusetts 01772
Re: K160053
Trade/Device Name: Monopolar Single-use HF Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: April 20, 2016 Received: April 21, 2016
Dear Mr. 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
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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.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Monopolar single-use HF cable
Indications for Use (Describe)
HF cable for electrotherapeutical use in endoscopic procedures in conjunction with compatible active accessories and compatible electrosurgical units.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Monopolar single-use HF cable
510(k) PREMARKET NOTIFICATION
SECTION 2 - 510k Summary
Olympus Winter & Ibe GmbH Hamburg, Germany
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510(k) Summary December 07, 2015
1. General Information
| Manufacturer: | Olympus Winter & Ibe GmbHKuehnstr. 6122045 HamburgGermany |
|---|---|
| Establishment Registration Number: 9610773 | |
| Official Correspondent: | Graham A.L. BaillieManager, Regulatory AffairsGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104Phone: 508.804.2738Fax: 508. 804.2624Email: Graham.baillie@olympus-osta.comEstablishment Registration No: 3003790304 |
2. Device Identification
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
|---|---|
| Regulation Number: | 878.4400 |
| Regulation Description: | Electrosurgical cutting and coagulation device and accessories |
| Device Class: | II |
| Product Code: | GEI |
| Review Panel: | General & Plastic Surgery |
| Proprietary/Trade Name: | Monopolar single-use HF cable |
3. Predicate Devices
| 510(k) No. | Name | Predicate Model No. | Product code /Reg No. |
|---|---|---|---|
| K944200/1 | HF-cable, monopolar | A0358 | GCJ / 876.1500FAS / 876.4300 |
| K890328 | Disposable Active Cord | DAC | |
| GEI / 878.4400HIH / 884.1690 |
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The predicates have not been subject to a design-related recall.
No reference devices were used in this submission.
4. Product Description
The Olympus monopolar single-use HF cable that is subject to this submission connects a compatible electrosurgical generator with the working element of a resectoscope for the application of monopolar HF current during endoscopic procedures.
The HF cable is delivered in sterile condition and is intended for single use only.
The monopolar single-use HF cable consists of a proximal plug connecting to the HF generator, an insulated cord and a distal plug connecting to the working element of the resectoscope.
5. Indications for Use
"HF cable for electrotherapeutical use in endoscopic procedures in conjunction with compatible active accessories and compatible electrosurgical units."
This intended use is essentially the same intended use as that of the predicate devices.
6. Comparison of Technological characteristics
The subject and predicate devices are based on the same technological principle with similar elements:
- I HF cable consisting of a proximal plug connecting to the HF generator, an insulated cord and a distal plug connecting to an active instrument
- 트 Predicate and subject devices are designed for use with monopolar current
- I Similar outer dimensions
- I Design changes of the HF cable are minor and do not negatively impact safety or effectiveness of the subject devices
- . There are no patient-contacting materials in predicates and subject device
While one of the predicate devices (A0538) is reusable and can be reprocessed, the other predicate (DAC) and the subject device are provided in sterile condition and are
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intended for single-use only. Accordingly, outside materials differ to suit differing durability needs. Also, material selection of the single-use predicate and subject device differ; however, durability of the new materials has been tested successfully.
7. Performance Data
The following performance data was provided in support of the substantial equivalence determination. All standards applied are FDA recognized international standards.
Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety was tested according to
| AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009and A2:2010 | Medical Electrical Equipment - Part 1.1 Generalrequirements for safety and essential performance. |
|---|---|
| AAMI/ANSI/IEC 60601-2-22009 | Medical Electrical Equipment - Part 2-2: ParticularRequirements for the Basic Safety And EssentialPerformance of High Frequency Surgical Equipmentand High Frequency Surgical Accessories |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: MedicalElectrical Equipment - Part 2-18: Particularrequirements for the basic safety and essentialperformance of endoscopic equipment. |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests |
Clinical Evaluation
Clinical and animal studies were not necessary.
A clinical evaluation has been conducted containing a comprehensive literature review.
Software
Not applicable as the HF cable does not contain any software.
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Performance Testing Bench
Conducted tests included the following tests:
- Insertion & Retraction Force tests of connectors -
- -Cable marking durability test
- Surface temperature measurement test -
- Cable insulation HF and Mains Dielectric Strength test -
- -Cable anchorage test
- Fluid ingress test -
- -Continuity test
- Cable tensile strength test -
- Connector grip test -
- Output power measurement -
- -Transport testing
8. Sterilization and Shelf Life
Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated.
A sterility assurance level (SAL) of 106 was reached during validation and will be used for routine sterilization in compliance with regulations in force for sterile medical devices.
The EtO residuals are within the limits after tunnel degassing time.
Shelf Life testing supports a shelf life of 1 year for the monopolar single-use HF cable.
9. Conclusion
The performance data support the safety of the device and demonstrate that the subject device complies with the intended use as specified.
In summary, we believe the monopolar single-use HF cable is substantially equivalent with the predicate devices with respect to the general design approach, function, and the intended use. The HF cable raises no new concerns of safety or effectiveness when compared to the predicate devices.
§ 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.