(116 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical and electrical properties of a cable, with no mention of AI or ML.
No
This device is a cable that connects an electrosurgical generator to other accessories; it delivers energy but does not perform a therapeutic function itself.
No
Explanation: The device description states it “connects a compatible electrosurgical generator with the working element of a resectoscope for the application of monopolar HF current during endoscopic procedures.” This indicates a therapeutic function by delivering current, not a diagnostic one.
No
The device is a physical cable with plugs and insulation, intended for single use and delivered sterile. The performance studies include bench testing of physical properties and electrical safety, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "HF cable for electrotherapeutical use in endoscopic procedures". This describes a device used in vivo (within the body) for therapeutic purposes (applying HF current).
- Device Description: The description reinforces this by explaining it connects an electrosurgical generator to a resectoscope for applying monopolar HF current during endoscopic procedures. This is a surgical/therapeutic application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing samples outside the body to gain diagnostic information. This device is designed for direct therapeutic intervention inside the body.
N/A
Intended Use / Indications for Use
HF cable for electrotherapeutical use in endoscopic procedures in conjunction with compatible active accessories and compatible electrosurgical units.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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, C1:2009 and A2:2010 Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance.
- AAMI/ANSI/IEC 60601-2-2 2009 Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety And Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories
- IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Medical Electrical Equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
- IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Clinical Evaluation
Clinical and animal studies were not necessary.
A clinical evaluation has been conducted containing a comprehensive literature review.
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
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.
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.
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.
No reference devices were used in this submission.
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
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
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.
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
2
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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EF
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3
Monopolar single-use HF cable
510(k) PREMARKET NOTIFICATION
SECTION 2 - 510k Summary
Olympus Winter & Ibe GmbH Hamburg, Germany
4
510(k) Summary December 07, 2015
1. General Information
| Manufacturer: | Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg
Germany |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 9610773 |
| Official Correspondent: | Graham A.L. Baillie
Manager, Regulatory Affairs
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104
Phone: 508.804.2738
Fax: 508. 804.2624
Email: Graham.baillie@olympus-osta.com
Establishment 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 / 876.1500
FAS / 876.4300 |
| K890328 | Disposable Active Cord | DAC | |
| | | | GEI / 878.4400
HIH / 884.1690 |
5
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
6
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, C1:2009
and A2:2010 | Medical Electrical Equipment - Part 1.1 General
requirements for safety and essential performance. |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI/IEC 60601-2-2
2009 | Medical Electrical Equipment - Part 2-2: Particular
Requirements for the Basic Safety And Essential
Performance of High Frequency Surgical Equipment
and High Frequency Surgical Accessories |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Medical
Electrical Equipment - Part 2-18: Particular
requirements for the basic safety and essential
performance of endoscopic equipment. |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - 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.
7
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.