(238 days)
No
The device description and performance studies focus on the electrical and mechanical properties of the cables, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The cables are accessories that connect electrosurgical generators to active accessories for electrosurgical use, acting as part of a system rather than directly performing a therapeutic function itself.
No
The device is described as HF-cables that connect electrosurgical generators to active accessories for electrosurgical use, indicating a therapeutic or procedural function rather than a diagnostic one.
No
The device is described as physical HF-cables that connect electrosurgical generators to accessories, are reusable, non-sterile, and autoclavable. The description focuses on physical characteristics, electrical and thermal safety, and reprocessing, indicating a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "electrosurgical use in laparoscopic, and open surgery". This describes a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a cable that connects electrosurgical generators to accessories for surgical procedures. It mentions being a "class II medical device accessory" under a regulation number related to "Electrosurgical cutting and coagulation device and accessories". This further reinforces its role in surgical intervention.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is a component of an electrosurgical system used during surgery, not a device used to perform diagnostic tests on samples.
N/A
Intended Use / Indications for Use
HF cables for electrosurgical use in laparoscopic, and open surgery in combination with compatible active accessories and compatible electrosurgical generators.
Product codes
GEI
Device Description
The HF-cables (see Table 2.1) subject to this submission are reusable, non-sterile devices, that connect electrosurgical generators as sender to compatible active accessories as receiver for electrosurgical use in laparoscopic, endoscopic, and open surgery. The devices are used as part of a system.
The HF-cables are class II medical device accessories under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery.
There are monopolar as well as bipolar HF-cable models subject of this submission. All of the subject HF-cables are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the cables must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The HF-cables are available with different cable lengths and with different plugs for the working element/instrument as well as for the electrosurgical generator side. The different plugs allow different compatibilities in accordance with their respective labeling.
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
Performance tests were carried out to ensure that the subject devices function as intended and meet design specifications. The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing: The HF-cables do not contain components that come directly or indirectly in patient contact. Biocompatibility testing according to ISO 10993 is not required.
Electrical Safety: The subject HF-cables have been successfully tested for electrical safety in accordance with AAMI/ANSI and IEC 60601 standards (please see list of applied FDA recognized standards below).
Thermal Safety: The subject HF-cables have been successfully tested for thermal safety in accordance with AAMI/ANSI and IEC 60601-1:2005/(R)2012 standards (please see list of applied standards below).
Performance Testing Bench: Conducted tests include tests with regard to design, transport and storage, repeated stress and mechanical performance testing.
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971.
Reprocessing: Required cleaning and sterilization procedures for the HF-cables are described in the respective instructions for use. All described methods are supported by respective validation test reports.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 19, 2023
Olympus Winter & Ibe GmbH % Christina Flores, RAC Manager, Regulatory Affairs Olympus Surgical Technologies of the Americas 800 West Park Drive Westborough, MA 01581
Re: K221522
Trade/Device Name: HF-cables (reusable) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: December 20, 2022 Received: December 20, 2022
Dear Christina Flores:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221522
Device Name HF-cables (reusable)
Indications for Use (Describe)
HF cables for electrosurgical use in laparoscopic, and open surgery in combination with compatible active accessories and compatible electrosurgical generators
| 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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3
510(k) Summary of Safety and Effectiveness
General Information 2.1
| Manufacturer/Holder | Olympus Winter and Ibe GmbH |
|---|---|
| Kuehnstr. 61 | |
| 22045 Hamburg | |
| Germany | |
| Establishment Registration No.: 9610773 | |
| Official Correspondent | Ms Christina Flores, RAC |
| Manager, Regulatory Affairs | |
| Olympus Surgical Technologies of the Americas | |
| 800 West Park Drive | |
| Westborough, MA 01581 | |
| Phone: (508) 808-3341 | |
| Email: Christina.Flores@olympus.com | |
| Establishment Registration No.: 3003790304 |
2.2 Device Identification
| Common Name: | HF-cables (reusable) |
|---|---|
| Regulation Number: | 21 CFR 878.4400 |
| Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Device Class: | II |
| Product Code: | GEI |
| Review Panel: | General & Plastic Surgery |
| Proprietary/Trade Name: | HF-cables (reusable) |
Table 2.1: List of devices subject to this submission
| Article No. | Article name |
|---|---|
| A00010A | HF-cable, monopolar |
| A00011A | HF-cable, monopolar |
| A00012A | HF-cable, monopolar |
| A0335.1 | HF-cable, monopolar |
| A0355 | HF-cable, monopolar |
4
| 510(k) Premarket Notification | |
|---|---|
| -- | ------------------------------- |
| Article No. | Article name |
|---|---|
| A0357 | HF-cable, monopolar |
| A0358 | HF-cable, monopolar |
| A0391 | HF-cable, monopolar |
| A0392 | HF-cable, monopolar |
| A0393 | HF-cable, monopolar |
| A60000C | HF-cable, bipolar |
| A60001C | HF-cable, bipolar |
| A60002C | HF-cable, bipolar |
| A60003C | HF-cable, bipolar |
| WA00013A | HF-cable |
| WA00014A | HF-cable, bipolar |
2.3 Predicate Device
The HF-cables (reusable) subject to this submission Table 2.1 are considered substantially equivalent to the following legally marketed predicate device identified in Table 2.2.
Table 2.2: Predicate Device
| Predicate Device | Device Name | 510(k) No. |
|---|---|---|
| WA00014A | HF-cable, bipolar | K120418 |
2.4 Device Description
The HF-cables (see Table 2.1) subject to this submission are reusable, non-sterile devices, that connect electrosurgical generators as sender to compatible active accessories as receiver for electrosurgical use in laparoscopic, endoscopic, and open surgery. The devices are used as part of a system.
The HF-cables are class II medical device accessories under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery.
There are monopolar as well as bipolar HF-cable models subject of this submission. All of the subject HF-cables are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the cables must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.
The HF-cables are available with different cable lengths and with different plugs for the working element/instrument as well as for the electrosurgical generator side. The different plugs allow
5
different compatibilities in accordance with their respective labeling.
2.5 Intended use and indications
HF cables for electrosurqical use in laparoscopic, and open surgery in combination with compatible active accessories and compatible electrosurgical generators.
The indications for use statement for the subject HF-cables is comparable to that of the predicate device. A slightly different wording is chosen and specific indications are added. Furthermore, the sentence "Do not use for any other purposes." was removed.
The differences do not alter the intended use of the devices nor do they raise different questions of safety and effectiveness of the device relative to the predicate.
2.6 Summary of Technological Characteristics
The technological characteristics of the subject devices are considered equivalent to the predicate device.
The subject devices and predicate device share the following characteristics:
- . general technology (HF-cables connecting electrosurgical generators as sender to compatible active accessories as receiver for electrosurgical use),
- . validated reprocessing methods, and
- o expected service life.
The following differences to the predicate device exist depending on the subject device model:
- design of plugs (different configurations of plugs for connectivity to the compatible . instrument and the electrosurgical generator of each HF-cable),
- max. rated voltage (only different for monopolar subject devices),
- . electrical resistance,
- . cable weight,
- comparable cable length,
- wire cross section,
- . number of single wires, and
- cable diameter/cable cross section.
As stated above, the subject and predicate devices have similar design characteristics and show comparable performance. As demonstrated in the non-clinical testing the different technological characteristics do not negatively alter the safety and effectiveness of the subject device.
6
2.7 Performance Data
Performance tests were carried out to ensure that the subject devices function as intended and meet design specifications. The following performance data were provided in support of the substantial equivalence determination.
■ Biocompatibility Testing
The HF-cables do not contain components that come directly or indirectly in patient contact. Biocompatibility testing according to ISO 10993 is not required.
Electrical Safety
The subject HF-cables have been successfully tested for electrical safety in accordance with AAMI/ANSI and IEC 60601 standards (please see list of applied FDA recognized standards below).
Thermal Safety
The subject HF-cables have been successfully tested for thermal safety in accordance with AAMI/ANSI and IEC 60601-1:2005/(R)2012 standards (please see list of applied standards below).
■ Performance Testing Bench
Conducted tests include tests with regard to design, transport and storage, repeated stress and mechanical performance testing.
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971.
Reprocessing
Required cleaning and sterilization procedures for the HF-cables are described in the respective instructions for use. All described methods are supported by respective validation test reports.
7
■ Applied Standards
Table 2.3: Applied FDA recognized standards
| Standards Number | Standard Title | FDA-Recognition
Number + date |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| AAMI/ANSI ES
60601-1:2005/(R)2012 and
C1:2009/(R)2012 and,
A2:2010/(R)2012 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD) | 19-4
07/09/2014 |
| IEC
60601-1-2
Ed. 4.0:
2014-02 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests | 19-8
09/17/2018 |
| IEC
60601-2-2
Ed. 6.0:
2017-03 | 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 | 6-389
06/07/2021 |
| IEC 60601-1-6
Edition 3.1
2013-10 | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability | 5-89
06/27/2016 |
| IEC 62366-1
Edition 1.0
2015-02 | Medical devices - Part 1: Application of usability
engineering to medical devices [Including
CORRIGENDUM 1 (2016)] | 5-114
12/23/2016 |
| ISO 14971
Second edition
2007-03-01 | Medical devices - Application of risk management to
medical devices | 5-40
06/27/2016 |
| ISO 10993-1
Fifth edition
2018-08 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process | 2-258
01/14/2019 |
| ISO 15223-1
Third edition
2016-11-01 | Medical devices -- Symbols to be used with medical
device labels, labelling and information to be supplied --
Part 1: General requirements | 5-117
08/21/2017 |
| ISO 17664
Second edition
2017-10 | Processing of health care products - Information to be
provided by the medical device manufacturer for the
processing of medical devices | 14-515
07/06/2020 |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping
Containers and Systems | 14-499
12/23/2016 |
2.8 Conclusion
The performance data demonstrates the safety of the device as well as compliance with listed recognized consensus standards.
In summary, Olympus believes the subject HF-cables are substantially equivalent to the predicate device with respect to the general design approach, function, and the intended use. The subject HF-cables raise no new concerns of safety or effectiveness compared to the predicate device.