(183 days)
Not Found
No
The summary describes a cable and tubing set for connecting existing electrosurgical and irrigation devices. There is no mention of any computational or analytical capabilities that would suggest AI/ML.
No
The device is used to connect other devices (forceps, generator, irrigation module) that are used to deliver therapy (coagulation and irrigation), but the device itself is a linking component and not directly therapeutic.
No
The device is described as providing irrigation and energy for coagulation, which are therapeutic functions, not diagnostic ones. There is no mention of the device collecting or analyzing data for diagnosis.
No
The device description clearly indicates a physical cable with connectors and tubing, which are hardware components. The performance studies also focus on hardware-related aspects like sterility, electrical safety, and packaging integrity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that provides irrigation and energy simultaneously to bipolar forceps for coagulation. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device description details a cable and tubing set used to connect surgical instruments (forceps) to electrosurgical generators and irrigation modules. This is consistent with a surgical accessory, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on sterility, safety standards (IEC, ISO), packaging integrity, and accelerated aging, which are typical for surgical devices, not IVDs.
In summary, the device's function and description clearly indicate it is a surgical accessory used during a procedure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or The Malis irrigation module 1000.
Product codes
GEI
Device Description
The device is single use and is used to connect an irrigation bipolar forceps to electrosurgical generator and irrigation module for coagulation and delivering saline to the tip of forceps simultaneously.
The socket connector of the cable is to fit Codman irrigating bipolar forceps. The fixed 2-pin plug is connected to any compatible generators or the flying lead connectors are connected to Malis bipolar coagulators or any compatible generators. The tubing set of the cable can be used with the Malis CMC-II irrigation module or the Malis irrigation module 1000.
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)
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014.
The safety performance of the subject device passed all the testing according to internal requirements and international standards shown below to support the substantial equivalence of the subject device
- IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment Part 1: -General requirements for basic safety and essential performance
- -IEC60601-2-2: 2017 (Fifth Ed), Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surqical equipment and high frequency surqical accessories.
- IEC60601-1-2:2014, Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance - Collateral Standard. Electromagnetic Disturbances - Requirements and Tests
- -ISO10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- -ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.
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
§ 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 19, 2021
Modern Medical Equipment Manufacturing, LTD. Philip Hung Management Representative Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street, Kwai Chung, N.T. Hong Kong, China
Re: K211170
Trade/Device Name: Single Use Irrigation bipolar cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 14, 2021 Received: September 20, 2021
Dear Philip Hung:
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 ffor 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/cfpm/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. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (0S) 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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211170
Device Name
Sterile Single Use Irrigation Bipolar Cable
Indications for Use (Describe)
The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or The Malis irrigation module 1000.
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
| 1. 510(k) Owner
| Name: | Modern Medical Equipment Manufacturing Limited | |
|---|---|---|
| Address: | Modern Medical Equipment Mfg., Ltd. | |
| Flat A, 11/F., Mai Wah Ind. Bldg., | ||
| 1-7 Wah Sing Street, | ||
| Kwai Chung, N.T., Hong Kong, China. | ||
| Telephone: | (852) 2420 9068 | |
| Fax: | (852) 2481 1234 | |
| Contact person: | Philip Hung | |
| Date of preparation: | 16 October 2021 | |
| 2. Device | ||
| Name of Device: | Sterile Single Use Irrigation Bipolar Cable | |
| Trade or proprietary name: | Sterile Single Use Irrigation Bipolar Cable | |
| Common or usual name: | Sterile Single Use Irrigation Bipolar Cord | |
| Classification name: | Electrosurgical Cutting & Coagulation | |
| Device & Accessories | ||
| Classification number: | 21 CFR 878.4400 | |
| Classification Panel: | General & Plastic Surgery | |
| Product Code: | GEI | |
| Class: | II |
3. Predicate device
Codman Integrated Irrigation Tubing and Bipolar Cord Set with 510(k) number K052449.
4. Device description
The device is single use and is used to connect an irrigation bipolar forceps to electrosurgical generator and irrigation module for coagulation and delivering saline to the tip of forceps simultaneously.
The socket connector of the cable is to fit Codman irrigating bipolar forceps. The fixed 2-pin plug is connected to any compatible generators or the flying lead connectors are connected to Malis bipolar coagulators or any compatible generators. The tubing set of the cable can be used with the Malis CMC-II irrigation module or the Malis
4
irrigation module 1000.
5. Indication for use
The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or the Malis irrigation module 1000.
6. Substantial Equivalence
The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. The following table shows the comparisons in more detail information among the subject devices and the predicate device.
| Compared
Items | Proposed Device
(K211170)
Single Use
Irrigation bipolar
cable (CD933) | Predicate Device
(K052449)
Coeman Integrated
Irrigation Tubing and
Bipolar Cord Set | Comments on
difference |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indication for
use | The device is
intended to provide
irrigation and
energy
simultaneously to
standard bipolar
forceps specifically
designed for
irrigation. The
device is used with
Malis bipolar
coagulators or the
compatible
generators and the
Malis CMC-II
Irrigation Module
or the Malis
irrigation module
1000. | The device is intended to
provide irrigation and
energy simultaneously to
bipolar forceps specifically
designed for irrigation.
They are intended for use
with Codman/Malis CMC-II
and the Codman/Malis
CMC III I.E.C. Irrigation
Modules and the
Codman/Malis Bipolar
Coagulators. | Same |
| Regulation
number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Product code | GEI | GEI | Same |
| OTC or
prescription | For prescription
use | For prescription use | Same |
| Energy
delivery | High frequency
electrical
current/energy | High frequency electrical
current/energy | Same |
| Technology | For monopolar
electrosurgery | For monopolar
electrosurgery | Same |
| Design | Combined of
Irrigation tubing
with bipolar cable | Combined of Irrigation
tubing with bipolar cable | Same |
| Material of the
components | | | |
| -
Cable wire
with plug | Copper wire and
PVC insulation | Copper wire and PVC
insulation | Same |
| -
Tubing | PVC | PVC | Same |
| -
Luer lock | PC | PC | Same |
| -
Puncture
utensil | ABS | ABS | Same |
| -
Protector
for luer and
puncture
utensil | ABS | LDPE/PP | Similar,
provide the
| same function |
|---|
| Pinch |
| clamp |
| Rated |
| accessory |
| voltage |
| IEC safety |
| requirements |
| Sterile |
| Shelf life |
| Electrical |
| safety and |
| EMC |
| dielectric strength |
| in with accordance |
| IEC60601-1, |
| IEC60601-1-2 & |
| IEC60601-2-2 |
| strength in with accordance |
| AAMI HF-18 |
| Biocompatibility |
| ISO10993 |
| biocompatibility |
| requirements so |
| it does not raise |
| any safety issue |
| for |
5
6
7. Non-clinical Performance Testing Data
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014.
The safety performance of the subject device passed all the testing according to internal requirements and international standards shown below to support the substantial equivalence of the subject device
- IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment Part 1: -General requirements for basic safety and essential performance
- -IEC60601-2-2: 2017 (Fifth Ed), Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surqical equipment and high frequency surqical accessories.
- IEC60601-1-2:2014, Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance - Collateral Standard. Electromagnetic Disturbances - Requirements and Tests
- -ISO10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- -ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.
8. Conclusion
The non-clinical testing demonstrates that the subject device, the Single Use Irrigation Bipolar Cable, is substantially equivalent as the predicate device (K052449).