(62 days)
Sure-Lock electrode clips provide a connection between lead wires and ECG/EKG electrodes (button & tab style).
ECG/EKG electrode clip
This document describes a Special 510(k) submission for a Sure-Lock electrode clip, focusing on changes to the device rather than a new AI/ML device. Therefore, many of the requested elements for an AI/ML device (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The acceptance criteria and "study" proving the device meets them are related to the safety and effectiveness of the proposed changes compared to the predicate device, demonstrated through non-clinical performance data and adherence to recognized standards.
Here's the breakdown of the information that is applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI EC53:1995 | Assessed to standard (Implied compliance) |
| ANSI/AAMI EC53/A1:1998 | Assessed to standard (Implied compliance) |
| Equivalence to predicate device K884592 | Achieved through nonclinical testing |
| Insulation material change (polymethylpentene to polycarbonate) | Verified through "Engineering Test Report: SURE-LOCK Material Comparison-Polymethylpentene and Makrolon 2458" |
| DFU/label change (3mm-4mm safety banana plug) | Verified through attached DFU/label update |
| DFU/label change (Caution: cleaning) | Verified through "Engineering Test Report: SURE-LOCK Connector Performance" and attached DFU/label update |
| DFU/label change (Note: 10 sterilization cycles by ETO) | Verified through "Engineering Test Report: ECG Cables and Leads Verification Testing" and attached DFU/label update |
| DFU/label change (compatible electrodes table) | Verified through "Engineering Test Report: SURE-LOCK Electrode Compatibility" and attached DFU/label update |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a device modification submission, not an AI/ML study involving a test dataset for algorithm performance. The "test set" here refers to the actual physical devices undergoing engineering testing. Data provenance would be from internal engineering tests conducted by Curbell Electronics, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of an AI/ML study is not relevant here. The "ground truth" for this device modification is compliance with established performance standards and the predicate device's baseline performance. This would have been established by Curbell's internal engineering and quality personnel.
4. Adjudication method for the test set
- Not Applicable. No human adjudication of diagnostic output from an algorithm is involved. Device performance testing would follow standard engineering and quality control procedures.
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
- Not Applicable. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
- For the physical device modifications, the "ground truth" involves compliance with industry performance standards (ANSI/AAMI EC53:1995 and EC53/A1:1998) and comparison to the established performance of the legally marketed predicate device (K884592). Additionally, internal engineering test reports serve as evidence for the specific material, cleaning, sterilization, and electrode compatibility changes.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
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Curbeil Electronics, Inc. www.rufbo.com/10/10/90/10/9/10/
Special 510(k) Summary
- Company: Curbell Electronics, Inc. 20 Centre Drive Orchard Park, NY 14127 716-667-3377 x419 716-667-1390 fax
MAY - 5 2008
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- Contact: Michael J. Winter
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- Date Prepared: February 29, 2008
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- Trade Name: Sure-Lock electrode clip
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- Common Name: ECG electrode connector clip
- Classification Name: Patient Transducer and Electrode Cable (including connector) 5. (21CFR870.2900, Product Code DSA)
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- Predicate device: Current 510(k) (K884592), Astro Trace, model AT-01
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- Device description: ECG/EKG electrode clip
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- Intended use: Sure-Lock electrode clips provide a connection between lead wires and ECG/EKG electrodes (button & tab style).
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- Technological characteristics to predicate device: The proposed change to the Sure-Lock electrode clip does not affect the equivalence to the former legally marketed predicate device, Astro Trace, model AT-01, (K8844592).
The differences in the proposed changes to the Sure-Lock electrode clip to the predicate device are the following:
- Change the insulator material from polymethylpentene to . polycarbonate (Makrolon). Reference Engineering Test Report: SURE-LOCK Material Comparison-Polymethylpentene and Makrolon 2458, Section 11.
- . Change the DFU/label to require a "3mm-4mm safety banana plug" instead of a "3mm-4mm banana plug." Reference attached DFU/label, Section 12.
Tel: 716.667.3377 Fax: 716.667 7508
20 Centre Drive Orchard Park, NY 14127
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Image /page/1/Picture/0 description: The image shows the word "CURBELL" in a bold, sans-serif font. The letters are large and closely spaced, with the "R" overlapping the "U" and the "B" overlapping the "E". Below the word, there are several thick, diagonal lines that are evenly spaced and angled upwards from left to right. The lines appear to be a design element associated with the brand name.
Curbell Electronics, Inc. www.rarbodnion.co.upn
- Change the DFU/label to add a Caution: "Cleaning with . alternate compounds and methods may damage product. Contact Curbell for cleaning assistance." Reference Engineering Test Report: SURE-LOCK Connector Performance, Section 11. Reference attached DFU/label, Section 12.
- Change the DFU/label to add a Note: "Sure-Lock Electrode . Clip may be subjected to 10 sterilization cycles by ethylene oxide method." Reference Engineering Test Report: ECG Cables and Leads Verification Testing, Section 11. Reference attached DFU/label, Section 12.
- Change the DFU/label to include: "The following electrodes . (reference electrode table in DFU/Label) have been tested and are suitable for use with Sure-Lock electrodes. Contact Curbell for application assistance." Reference Engineering Test Report: SURE-LOCK Electrode Compatibility, Section 11. Reference attached DFU/label, Section 12.
Nonclinical performance data: 10.
The proposed changes to the Sure-Lock electrode clip have been assessed to the following performance standards:
- ANSI/AAMI EC53:1995 and EC53/A1:1998. �
- Clinical data: None 11.
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- Conclusion from nonclinical testing: There are no questions or differences in the safety and effectiveness of the proposed changes to the Curbell Sure-Lock electrode clip to the predicate device.
Tal: 716.667.3377 Fax: 716.667 7508
20 Centre Drive Orchard Park, NY 14127
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2008
Curbell Electronics, Inc. c/o Mr. Michael J. Winter, RAC Director, Quality and Regulatory Affairs 20 Center Dr. Orchard Park, NY 14127
Re: K080605
Sure-Lock Electrode Clip, Model CL-34, CL-A60, CL-HW, CL-TL Regulation Number: 21 CFR 870,2900 Regulation Name: Patient Transducer and Electrode Cable (including connector) Regulatory Class: Class II (two) Product Code: DSA Dated: April 8, 2008 Received: April 14, 2008
Dear Mr. Winter:
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.
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Page 2 - Mr. Michael J. Winter, RAC
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); 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 Scction 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
une R. Vahner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K080605
Device Name: Sure-Lock Electrode Clip
Indications For Use: Sure-Lock electrode clips provide a connection between lead wires and ECG/EKG electrodes (button & tab style).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. V. Russell
Page 1 of 1
Vision Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number جي مصر 100(k) 10)
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).