(168 days)
joimax® Bipolar Electrosurgical Instruments
The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.
joimax® Monopolar Electrosurgical Instruments
The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator.
The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
The joimax® Electrosurgical Instruments are comprised of a series of instruments to facilitate the delivery of electrical energy from an RF generator to the patient tissue for use in cutting and/or coagulation of tissue.
The joimax® Electrosurgical Instruments use Radio Frequency (RF) energy to induce thermal effects on tissue. The radio frequency is generated by high oscillating electrical current received from a commercially available RF generator.
The joimax® Probes are available in both monopolar and bipolar probe configurations. All joimax® Probes are designed for specific use with joimax® Handpieces. The joimax Handpieces can be used with compatible commercially available surgical generators.
The provided text discusses the joimax® Electrosurgical Instruments and their substantial equivalence to predicate devices, focusing on safety and performance. However, it does not explicitly detail a study with specific acceptance criteria and detailed performance metrics as one might expect for an AI/ML device. The document primarily focuses on demonstrating that the electrosurgical instruments meet general safety and performance standards equivalent to existing legally marketed devices.
Based on the provided text, here's a breakdown of the requested information, noting where specific details are not available for this type of device (e.g., sample sizes for AI/ML models, expert ground truth for image interpretation).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance results in a quantitative manner for a comparative study against a specific numerical target. Instead, it confirms compliance with various standards and qualitative comparisons to predicate devices. The "acceptance criteria" are implied by adherence to these standards and the demonstration of similar performance to predicates.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | The device was evaluated according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Testing included Cytotoxicity, Irritation, Sensitization, and Acute Systemic Toxicity. The joimax® electrosurgical instruments are considered direct tissue contacting for < 24 hours and the tests confirm biological safety. |
| Sterilization/Shelf-Life | Bipolar instruments: Validated to achieve a sterility assurance level of 10⁻⁶ using ISO 11137-1/-2. Disposable monopolar instruments: Adopted into a validated EO cycle following AAMI TIR 28:2009. Reusable instruments Moist Heat Sterilization: Validated per ISO 17665-1. Packaging: Validated to ensure sterile barrier integrity per ISO 11607-1. |
| Electrical Safety | Complies with IEC 60601-1 standard for safety. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard for EMC. |
| Performance (Functional) | Dimensional and Physical Properties: Verification performed to demonstrate instruments met specifications and confirmed physical properties. Ex-vivo Testing: Conducted using multiple types of soft animal tissue (kidney, liver, and muscle tissue). Testing included all ranges of relevant parameters (power settings, activation duration, waveforms/frequencies). Effect on tissue was assessed and determined to be highly comparable to the predicate device. The instruments met all specified criteria and did not raise new safety or performance questions. Performance was found to be similar to the predicate device, indicating suitability for intended use (cutting and/or coagulation of soft tissue). |
| Substantial Equivalence | The testing demonstrated that the performance of the joimax® Electrosurgical Instruments is equal to the legally marketed predicate devices, thus establishing substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For the performance testing, the document states: "Ex-vivo testing was conducted using multiple types of soft animal tissue (kidney, liver and muscle tissue)." It does not specify a numerical sample size for the ex-vivo test set, nor does it provide provenance details like country of origin or whether the data was retrospective or prospective. This is typical for device performance testing involving animal tissue, where the focus is on demonstrating functional equivalence under controlled conditions rather than clinical dataset characteristics.
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 (number and qualifications of experts for ground truth) is usually relevant for AI/ML devices that interpret data (e.g., images). For electrosurgical instruments, "ground truth" related to tissue effect is typically established through direct observation, standardized pathological assessment, or established physical/chemical measurements by qualified technical personnel or pathologists, rather than expert consensus on interpretation. The document does not specify the number or qualifications of experts involved in assessing the ex-vivo tissue effects, but rather that effect was "assessed."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML studies where human interpretation of complex data (like medical images) is involved. For performance testing of electrosurgical devices, the assessment of tissue effect is often based on objective measurements or standardized observational criteria, and thus explicit adjudication among multiple reviewers isn't usually described in this context. The document does not mention any adjudication method for the performance test set.
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
An MRMC comparative effectiveness study is not mentioned as this device is an electrosurgical instrument, not an AI-assisted diagnostic or interpretive system that human readers would use to improve their performance. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical electrosurgical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here. The performance described is of the physical instrument itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing, the "ground truth" for the effect on tissue was likely established through direct observation during ex-vivo testing and possibly subsequent pathological assessment, although pathology is not explicitly named. The document states, "Effect on tissue was assessed and determined to be highly comparable to the predicate device." This "assessment" forms the basis of the functional ground truth for the device's intended use.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/ML device with a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
joimax® GmbH % Mr. Gary Mocnik Gary S. Mocnik and Associates 49 Coastal Oak Aliso Viejo, California 92656
Re: K161378
Trade/Device Name: joimax® Electrosurgical Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 3, 2016 Received: October 4, 2016
Dear Mr. Mocnik:
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 of medical devicerelated 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.
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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,
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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Indications for Use
510(k) Number (if known) K161378
Device Name joimax® Electrosurgical Instruments
Indications for Use (Describe)
joimax® Bipolar Electrosurgical Instruments
The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.
Model JVP32024 Vaporflex® Probe, Bipolar, Ball Tip 320 Model JVP27525S Vaporflex® Probe, Bipolar, Ball Tip 275 Model JVP25024 Vaporflex® Probe, Bipolar, Ball Tip 250 Model JBPP27020 Legato® Probe, Bipolar, Ball Tip 270 Model JBPH352505 Legato® Handpiece, Bipolar, for Surgi-Max / Endovapor® Model JVC35010 Vaporflex® Cable, for Surgi-Max / Endovapor Model JVH32030 Vaporflex® Handle and Shaft, 320 Model JVHS27527S Vaporflex® Irrigation Shaft 275 Model JVHS32030 Vaporflex® Shaft 320 Model JVHS25030 Vaporflex® Shaft 250 Model JVUH10010 Vaporflex® Handle Model JVHP10023 Vaporflex® Spare Sealing Rings
joimax® Monopolar Electrosurgical Instruments
The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator.
The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Model JMPP27025 Legato® Probe, Monopolar Model JMPH352504 Legato® Handpiece, Monopolar, for ValleyLab Model VLT381645 Vaporflex® / Legato® Sterilization Tray Model VLTC3816 Vaporflex® / Legato® Sterilization Tray with Lid
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
- I. This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
SUBMITTER: joimax® GmbH Amalienbadstrasse 41 RaumFabrik 61 76227 Karlsruhe, Germany
Contact person: Gary Mocnik Phone: (949) 433-0413 Date prepared: October 31, 2016
- II. DEVICE
Name of the device: joimax® Electrosurgical Instruments Common of usual name: Electrosurgical probes and accessories Classification name: Electrosurgical cutting and coagulation device Regulatory Class: 2 Product Code: GEI
III. PREDICATE DEVICE Primary Monopolar Predicate: Aaron Reusable Electrosurgical Electrode (K014201) Primary Bipolar Predicate: Bi Polar TRIGGER-Flex Electrode (K003126)
IV. DEVICE DESCRIPTION
The joimax® Electrosurgical Instruments are comprised of a series of instruments to facilitate the delivery of electrical energy from an RF generator to the patient tissue for use in cutting and/or coagulation of tissue.
The joimax® Electrosurgical Instruments use Radio Frequency (RF) energy to induce thermal effects on tissue. The radio frequency is generated by high oscillating electrical current received from a commercially available RF generator.
The joimax® Probes are available in both monopolar and bipolar probe configurations. All joimax® Probes are designed for specific use with joimax® Handpieces. The joimax Handpieces can be used with compatible commercially available surgical generators.
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- V. INDICATIONS FOR USE joimax® Bipolar Electrosurgical Instruments The joimax® bipolar Vaporflex and Legato electrosurgical instruments are used for coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator. The joimax® bipolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. Model JVP32024 Vaporflex® Probe, Bipolar, Ball Tip 320 Model JVP27525S Vaporflex® Probe, Bipolar, Ball Tip 275 Model JVP25024 Vaporflex® Probe, Bipolar, Ball Tip 250 Model JBPP27020 Legato® Probe, Bipolar, Ball Tip 270 Model JBPH352505 Legato® Handpiece, Bipolar, for Surgi-Max / Endovapor® Model JVC35010 Vaporflex® Cable, for Surgi-Max / Endovapor Model JVH32030 Vaporflex® Handle and Shaft, 320 Model JVHS27527S Vaporflex® Irrigation Shaft 275 Model JVHS32030 Vaporflex® Shaft 320 Model JVHS25030 Vaporflex® Shaft 250 Model JVUH10010 Vaporflex® Handle
Model JVHP10023 Vaporflex® Spare Sealing Rings
joimax® Monopolar Electrosurgical Instruments
The joimax® monopolar Legato electrosurgical instruments are used for cutting and/or coagulating soft tissue during open or minimally invasive surgical procedures when used in conjunction with a compatible radio frequency generator.
The joimax® monopolar electrosurgical instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Model JMPP27025 Legato® Probe, Monopolar Model JMPH352504 Legato® Handpiece, Monopolar, for ValleyLab Model VLT381645 Vaporflex® / Legato® Sterilization Tray Model VLTC3816 Vaporflex® / Legato® Sterilization Tray with Lid
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Electrosurgical instruments, by nature, are instruments intended to deliver electrical energy directly to tissue to facilitate tissue cutting/coagulation in surgical applications.
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The primary predicate devices (Aaron Reusable Electrosurgical Electrode, K014201; Bi Polar TRIGGER-Flex Electrode, K003126) and reference predicates (Arthrex Opes Electrodes and Accessories, K023986; Meddusa BiPolar System, K130110) were used to demonstrate substantial equivalence.
At a high level, the subject and predicate devices are based on the following same technological elements:
- All devices use electrical energy to generate high-frequency (RF) energy as a means to cut and/or coagulate tissue
- . All instrument sets are comprised of a cutting tool (e.g. electrode), an ergonomic user interface (e.g. handpiece) and a connector (e.g. cable) to the generator
- The joimax® monopolar electrode, the Aaron and Arthrex Opes monopolar . electrode predicates are all ball tipped.
- The ball diameter of the joimax® monopolar electrode (2.5 mm) is within I the diameters (2 mm-5 mm) of the predicate device. The tip diameter (2.0 mm) for the joimax® bipolar electrodes is well within the established diameters of the predicate device (1-3 mm).
- . The joimax® bipolar electrode shaft diameters (2.0 mm, 2.75 mm) are also within the established diameters of the predicate device (1-3 mm).
- The joimax® instruments shaft lengths (250-320 mm) are within the shaft . length range of the predicate device (monopolar: 130-343 mm, bipolar 180-400 mm).
- The ioimax® handpieces come in two configurations, namely a pencil ■ design and a handled design. These designs are consistent with the handpiece designs of the predicate device which also come in pencil or handled configurations.
- The connecting cable length of the joimax® electrosurgical instruments is . 3.5 meters, which is similar to the predicate Aaron device cable length and the Trigger-Flex cable length of approximately 3 meters.
- The joimax® handpieces and the predicate Arthrex Opes handpieces are I provided non-sterile and are intended to be sterilized by the user.
VII. PERFORMANCE DATA
Biocompatibility Testing
The biocompatibility evaluation for the Brand X device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of
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testing included the following tests:
- Cytotoxicity ●
- Irritation
- Sensitization
- Acute Systemic Toxicity ●
The joimax electrosurgical instruments are considered direct tissue contacting for < 24 hours.
Sterilization/Shelf-Life
The bipolar instruments were validated to achieve a sterility assurance level of 10 6 using ISO 11137-1/-2 (bipolar instruments). The disposable monopolar instruments were adopted into a validated EO cycle following AAMI TIR 28:2009. The reusable instruments moist heat sterilization cycle was validated per ISO 17665-1. Packaging validation was performed to ensure the devices provided sterile maintain their sterile barrier integrity following the requirements outlined in ISO 11607-1.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the joimax® electrosurgical instruments. The instruments comply with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Performance Testing
Performance testing was conducted for the joimax® Electrosurgical Instruments to demonstrate the suitability of the device for its intended use. The results of the testing indicate that the joimax® Electrosurgical Instruments is substantially equivalent to the predicate devices and is safe and effective for its intended use.
Dimensional and Physical Properties Verification was performed to demonstrate the instruments met their specifications and confirmed the physical properties of the devices. Ex-vivo testing was conducted using multiple types of soft animal tissue (kidney, liver and muscle tissue). Testing included all ranges of relevant parameters, such as power settings, activation duration, and waveforms / frequencies. Effect on tissue was assessed and determined to be highly comparable to the predicate device.
The joimax® Electrosurgical Instruments met all specified criteria and did not raise new safety or performance questions. Based on the design verification performance the joimax® Electrosurgical Instruments was found to have a safety and effectiveness profile that is similar to the predicate device.
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VIII. CONCLUSIONS
The testing performed for the joimax® Electrosurgical Instruments demonstrated that the performance of the joimax® Electrosurgical Instruments is equal to the legally marketed 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.