(63 days)
The NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe for the purpose of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.
The Handpiece is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical grade tubing with standard luer fittings. The Handpiece is ABS plastic and incorporates a stainless steel probe designed to operate in the bipolar mode when connected to any compatible bipolar electrosurgical generator capable of low energy output control. The irrigation and aspiration sets provide for connection of the handpiece to irrigation and aspiration devices.
The provided text describes a 510(k) premarket notification for a medical device, the NeoMedix MicroSurgical Bipolar Handpiece. However, it does not include a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/algorithm-based device would.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with established standards for safety.
Therefore, for aspects like "AI/algorithm performance," "sample size for test/training sets," "expert ground truth establishment," or "MRMC studies," the information is not present because this is a traditional medical device submission, not an AI/software device submission.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Compliance |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Demonstrated through biocompatibility studies of all patient contact materials. |
| Electrical Safety | IEC 60601-1 (leakage current) | Compliance to applicable requirements. |
| Electrical Safety | ANSI/AAMI HF-18 (handpiece dielectric voltage) | Compliance to applicable requirements. |
| Physical Integrity | Connector integrity | Physical testing performed. |
| Physical Integrity | Tip bend resistance | Physical testing performed. |
| Physical Integrity | Fluidic flow capability | Physical testing performed. |
| Sterility | Sterility Assurance Level (SAL) | Conforms to SAL of 10⁻⁶. |
2. Sample sizes used for the test set and the data provenance
- Not applicable / Not provided. This type of information (sample size, data provenance) is typically for studies involving data analysis or algorithm performance, which is not the primary focus of this 510(k) submission. The "testing" here refers to engineering and safety tests rather than clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. Ground truth establishment by experts is relevant for diagnostic or AI-driven devices. This submission relies on engineering standards and physical testing.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods are relevant for expert review processes, which are not detailed here.
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
- No. An MRMC study was not done, as this is not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a surgical handpiece, not an algorithm.
7. The type of ground truth used
- Physical/Engineering Standards and Biocompatibility Testing. The "ground truth" for this device's performance is compliance with established international and national standards for material safety (biocompatibility), electrical safety, and mechanical integrity.
8. The sample size for the training set
- Not applicable / Not provided. This refers to training data for algorithms, which is not relevant to this device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This refers to ground truth for training data for algorithms, which is not relevant to this device.
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FEB 2 5 2003
SECTION 2 - 510 (k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS
Date Prepared: November 25, 2002
Manufacturer and Submitter
NeoMedix Corporation 27452 Calle Arroyo San Juan Capistrano, California 92675 Phone: (949) 248-7029 Fax: (949) 248-7119
Contact Person
Dr. Soheila Mirhashemi
Common, Classification and Proprietary Names
- Electrosurgical electrode Common Name:
- Classification names: Electrosurgical cutting and coagulation device and accessories (21 CFR section 878.4400) and Radio frequency cautery device (21 CFR section 886.4100)
- Microsurgical Bipolar Handpiece Proprietary Name:
Predicate Devices
The NeoMedix MicroSurgical Bipolar Handpiece is similar in indications, design and features to the following currently marketed devices: Bipolar probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587) and Wolf Multifunction Instrument (K002000).
Indications for Use
The NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.
Device Description
The Handpiece is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical grade tubing with standard luer fittings. The Handpiece is ABS plastic and incorporates a stainless steel probe designed to operate in the bipolar mode when connected to any compatible bipolar electrosurgical generator capable of low energy output control. The irrigation and aspiration sets provide for connection of the handpiece to irrigation and aspiration devices.
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Technological Characteristics Comparison
The probe is similar in design to currently marketed bipolar probes (Mentor, Kirwan, Storz) in that the application of radio frequency current is bipolar in nature and occurs at the probe tip. The basic coaxial electrode design has been modified to include a protective foot to shield underlying tissue from current flow. This modification does not affect the safety or effectiveness of the device. A polyimide electrode insulation material provides the electrical isolation between the active and return bipolar electrodes. The irrigation and aspiration capabilities are similar to those in the Richard Wolf Multifunction Instrument. The bipolar electrical connector pins are compatible with standard bipolar cables that connect to an electrosurgical radio frequency generator, such as those used for the Storz, Mentor, Kirwan probes. The construction materials used have an established history of safe use in similar medical devices.
Performance and Safety
The biological safety of the device has been demonstrated through biocompatibility studies of all patient contact materials in accordance with the standards outlined in ISO 10993-1. Electrical safety has been demonstrated by compliance to applicable requirements defined in IEC 60601-1 for leakage current and ANSI/AAMI HF-18 for handpiece dielectric voltage. Physical testing was performed to assure connector integrity, tip bend resistance and fluidic flow capability. The device is supplied sterile and sterility will conform to a Sterility Assurance Level (SAL) of 10 °. The supplied Instructions for Use provide the user with the applicable warnings and cautions during use. There are no known contraindications. There are no new safety or effectiveness issues related to this device.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2003
Underwriters Laboratories, Inc. Robert M. Boonstra Senior Staff Engineer 2600 N.W. Lake Road Camas, Washington 98607-8542
Re: K024304
Trade/Device Name: MicroSurgical Bipolar Handpiece Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: Class II Product Code: GEI; HQR Dated: February 7, 2003 Received: February 11, 2003
Dear Mr. Boonstra:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 – Mr. Robert M. Boonstra
(21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
MicroSurgical Bipolar Handpiece
The NeoMedix MicroSurgical Bipolar Handpiece is to be used Indications for use: in electrosurgical applications where low power radio frequency current is applied through a bipolar probe for the purpose of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | ✓ |
|---|---|
| OR Over-the-counter: |
for
Mark N Melleman
(Division Sign-Off)
Division of General. Restorative
| 510(k) Number | K024304 |
|---|---|
| --------------- | --------- |
§ 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.