(62 days)
Not Found
No
The device is a simple electrode clip and the summary contains no mention of AI, ML, or related concepts.
No
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device, an ECG/EKG electrode clip, is used for diagnostic purposes by connecting lead wires to electrodes for signal acquisition, not for therapy.
No
This device is an electrode clip that connects lead wires to ECG/EKG electrodes, which are used for diagnostic purposes. However, the clip itself does not perform any diagnostic function; it is a component used in the diagnostic process.
No
The device description clearly states it is an "ECG/EKG electrode clip," which is a physical hardware component used to connect lead wires to electrodes. The performance studies also refer to "nonclinical performance data" and assessment to "performance standards" related to the physical clip. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a connection between lead wires and ECG/EKG electrodes. This is a physical connection for electrical signals, not a test performed on biological samples in vitro (outside the body).
- Device Description: It's described as an "ECG/EKG electrode clip," which aligns with its function as a connector for an in vivo (within the body) diagnostic procedure (ECG/EKG).
- Lack of IVD Characteristics: The description 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 biological samples
- Providing information about a patient's health status based on in vitro analysis.
The performance testing mentioned (ANSI/AAMI EC53) is related to the electrical and mechanical performance of ECG electrodes and accessories, which is consistent with a device used for in vivo ECG procedures.
N/A
Intended Use / Indications for Use
Sure-Lock electrode clips provide a connection between lead wires and ECG/EKG electrodes (button & tab style).
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
ECG/EKG electrode clip
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)
Nonclinical performance data: 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the word "CURBELL" in a bold, sans-serif font. The letters are large and closely spaced, creating a strong visual impact. Below the word, there are several diagonal lines that appear to be a design element, possibly suggesting movement or direction. The overall design is simple yet effective, with a focus on the brand name and a dynamic visual element.
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
-
- Contact: Michael J. Winter
-
- 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
1
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
2
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.
3
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
4
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)