Curbell branded Patient Monitoring Cables
Device Facts
| Record ID | K182220 |
|---|---|
| Device Name | Curbell branded Patient Monitoring Cables |
| Applicant | Curbell Medical Products, Inc. |
| Product Code | DSA · Cardiovascular |
| Decision Date | Nov 7, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.2900 |
| Device Class | Class 2 |
Indications for Use
Curbell patient cables are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.
Device Story
Curbell Patient Monitoring Cables consist of shielded/unshielded leadwires and trunk cables; connect electrodes, sensors, or catheters to patient monitors; facilitate ECG, EKG, and SpO2 signal transmission. Used in clinical settings by healthcare professionals. Cables feature copper wiring with PVC or thermoplastic polyurethane jackets; various connectors (snap, pinch, Sure Lock). Device acts as passive conduit for physiological signals; enables monitoring/diagnostic evaluation. Benefits include reliable signal transmission for patient monitoring.
Clinical Evidence
Bench testing only. No clinical data. Performance verified via ANSI/AAMI EC53:2013 (noise, flex life, tensile strength, connector retention, contact resistance, dielectric withstand) and IEC 60601-1:2005 (patient leads). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Shielded/unshielded copper wiring; PVC or thermoplastic polyurethane jackets. Connectors: snap, pinch, or Sure Lock. Lengths: 7-20ft (trunk), 18-120" (leadwires). Standards: ANSI/AAMI EC53:2013, IEC 60601-1:2005 (3rd Ed). Biocompatibility: ISO 10993-5, ISO 10993-10. Non-sterile. Passive electrical connectivity.
Indications for Use
Indicated for patients requiring ECG, EKG, and SpO2 monitoring via connection of electrodes, sensors, or catheters to a monitoring device for diagnostic evaluation by a healthcare professional.
Regulatory Classification
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.
Predicate Devices
- Curbell Patient Monitoring Cables (K081762)
- Shenzhen Med-link Electronics Tech Co., Ltd. patient cables and lead wires (K120010)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Curbell Medical Products, Inc. Michael Winter Sr. Director, Quality and Regulatory Affairs 20 Centre Drive Orchard Park, New York 14127
Re: K18220
Trade/Device Name: Curbell Patient Monitoring Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: August 10, 2018 Received: October 16, 2018
## Dear Michael 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. 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/cfpmn/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Todd D. Courtney -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K182220
Device Name Curbell Patient Monitoring Cables
Indications for Use (Describe)
Curbell patient cables are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.
| 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)
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Image /page/3/Picture/2 description: The image shows the logo for CURBELL MEDICAL. The word "CURBELL" is written in a large, bold, blue font. Below "CURBELL" is the word "MEDICAL" in a smaller, green font. The logo is simple and professional.
### Special 510(k) Summary
| 1. | Company: | Curbell Medical Products, Inc.<br>20 Centre Drive<br>Orchard Park, NY 14127<br>716-667-3377 x419 |
|----|----------|--------------------------------------------------------------------------------------------------|
|----|----------|--------------------------------------------------------------------------------------------------|
- 2. Contact: Michael Winter
- 2. Date Prepared: October 10, 2018
- 3. Trade Name: Curbell Patient Monitoring Cables
- 4. Common Name: Patient Monitoring Cables SAC-JAJA-007-000, Length: 6' 7'' Models: SAC-JAJA-010-000, Length 10' SAC-JAJA-025-000, Length: 25'
- న్. Classification Name: Patient Transducer and Electrode Cable (including connector) (21CFR870.2900, Product Code DSA)
- Primary Predicate: Curbell Patient Monitoring Cables: 510(k) 6. Predicate device(s): K081762 Secondary Predicate for Expanded Use (SPO2 Monitoring): Shenzhen Med-link Electronics Tech Co., Ltd. patient cables and lead wires: K120010
- 7. Curbell Patient Monitoring Cables comprise cables and lead Device description: wires that connect from sensors and/or electrodes to a monitor for the purpose of conducting ECG diagnosis, monitoring, and SPO2 monitoring. As per 21CFR801.109, this device is a prescription device.
- 8. Intended use: Curbell patient cables are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.
- 9. Technological characteristics to predicate device: Curbell Patient Monitoring Cables are substantially equivalent to the primary predicate device, Curbell Medical Products, Inc. (K081762). Additionally, they are substantially equivalent for expanded use (SPO2 Monitoring) to the secondary predicate device. Shenzhen Medlink Electronics Tech Co., Ltd. patient cables and lead wires: (K120010). This logic follows "Multiple Predicates Example 2", page 11, FDA Guidance Document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]."
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Image /page/4/Picture/1 description: The image shows the logo for CURBELL MEDICAL. The word "CURBELL" is written in a large, bold, blue font. Below it, the word "MEDICAL" is written in a smaller, green font. The logo is simple and modern.
| | Proposed Curbell<br>Patients Cables | Current Curbell<br>Patient Cables (Primary<br>Predicate) | Shenzhen Med-link Electronics<br>Tech Co., Ltd.<br>(Secondary Predicate – SPO2<br>Monitoring) |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182220 | K081762 | K120010 |
| Intended use | Curbell patient cables<br>are used to connect<br>electrodes and/or<br>sensors placed at the<br>appropriate sites on the<br>patient to a monitoring<br>device for general<br>monitoring and/or<br>diagnostic evaluation<br>by a healthcare<br>professional. | Curbell patient cables<br>are used to connect<br>electrodes and/or<br>sensors placed at the<br>appropriate sites on the<br>patient to a monitoring<br>device for general<br>monitoring and/or<br>diagnostic evaluation<br>by a healthcare<br>professional. | The Shenzhen Med-link cables<br>and lead wires are intended to<br>be used with ECG, EKG, SPO2<br>and Invasive Blood Pressure<br>monitoring devices. The patient<br>cables and lead wires are used<br>to connect electrodes, catheters,<br>and/or sensors placed<br>at appropriate sites on the<br>patient to a monitoring device<br>for general monitoring and/or<br>diagnostic evaluation by health<br>care professional. |
| Regulation | 21CFR870.2900 | 21CFR870.2900 | 21CFR870.2900 |
| Product code | DSA | DSA | DSA |
| Common Name | Patient cables and<br>leadwires | Patient cables and<br>leadwires | Patient cables and<br>leadwires |
| Proprietary Name | Curbell branded | Curbell branded | NA |
| Design/Materials | Shielded and unshielded<br>patient leadwires and<br>shielded patient trunk<br>cables with electrode<br>connectors including<br>snap, pinch, or Sure<br>Lock electrode clip.<br>Trunk cable lengths<br>include - 7 to 20ft.<br>Leadwire lengths from<br>18" to 120". Wire<br>material is comprised of<br>shielded and unshielded<br>copper with PVC or<br>thermoplastic<br>polyurethane jacket. | Shielded and unshielded<br>patient leadwires and<br>shielded patient trunk<br>cables with electrode<br>connectors including<br>snap, pinch, or Sure<br>Lock electrode clip.<br>Trunk cable lengths<br>include - 7 to 20ft.<br>Leadwire lengths from<br>18" to 120". Wire<br>material is comprised of<br>shielded and unshielded<br>copper with PVC or<br>thermoplastic<br>polyurethane jacket. | ECG and EKG Cables with<br>various connectors (monitor,<br>trunk/lead wire, electrode<br>grabber & snapper). SPO2<br>adapter cables with<br>various connectors for connect<br>for the OEM Instrument<br>connector of SPO2 monitor and<br>SPO2 probe.<br>Cable is set at various specified<br>standard lengths.<br>Wire material is comprised of<br>shielded and unshielded copper<br>with PVC or thermoplastic<br>polyurethane jacket. |
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Image /page/5/Picture/2 description: The image contains the logo for CURBELL MEDICAL. The word "CURBELL" is in large, bold, blue letters. Underneath "CURBELL" is the word "MEDICAL" in smaller, green letters. The logo is simple and professional.
| MEDICAL | | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Biocompatibility | Meets ISO 10993-5<br>Cytotoxicity,<br>ISO 10993-10<br>Sensitization, and<br>ISO 10993-10 Irritation. | Meets ISO 10993-5<br>Cytotoxicity,<br>ISO 10993-10<br>Sensitization, and<br>ISO 10993-10 Irritation | Meets ISO 10993-5<br>Cytotoxicity,<br>ISO 10993-10 Sensitization,<br>and<br>ISO 10993-10 Irritation |
| Sterility | Non sterile | Non sterile | Non sterile |
| Electrical<br>performance<br>testing | ANSI/AAMI EC53:<br>2013 | ANSI/AAMI EC53:<br>1995 (revised 2001) | ANSI/AAMI EC53:1995<br>(revised 2001) |
| Electrical Safety<br>testing | ANSI/AAMI EC53:<br>2013, IEC 60601-1:<br>2005, 3rd Edition<br>standard - Part 8.5.2.3<br>Patient Leads | ANSI/AAMI EC53:<br>1995 (revised 2001) | ANSI/AAMI EC53:1995<br>(revised 2001), IEC 60601-<br>1:1998;Am1, A2:1995 |
| Connector<br>Retention Force | ANSI/AAMI EC53:<br>2013 | ANSI/AAMI EC53:<br>1995 (revised 2001) | ANSI/AAMI EC53:1995<br>(revised 2001) |
The proposed Curbell Patient Monitoring Cables have the following similarities to the current Curbell primary predicate device:
- Same indications for use
- Same manufacturing process ●
- Similar monitor connector and similar yoke connector ●
- Same fundamental scientific technology .
The proposed Curbell Patient Monitoring Cables have the following similarities to the Shenzhen Med-link secondary predicate device:
- Same intended use (patient monitoring).
- Included indication for use (SPO2 monitoring) ●
- Similar/equivalent construction ●
- Same fundamental scientific technology ●
The proposed Curbell Patient Monitoring Cables have the following differences to the current Curbell primary predicate device:
- · Expanded Intended Use (SPO2 monitoring)
The proposed Curbell Patient Monitoring Cables have the following differences to the Shenzhen Med-link secondary predicate device:
- Color
- Length variations .
Curbell Reports that provide data and analysis to support the claims provided within:
- Engineering Verification and Validation Protocols .
- I Med-link device (secondary predicate)
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Image /page/6/Picture/2 description: The image shows the logo for CURBELL MEDICAL. The word "CURBELL" is written in large, bold, blue letters. Below "CURBELL" is the word "MEDICAL" in smaller, green letters. The logo is simple and professional.
- ANSI/AAMI EC53:2013 I
- 5.3.2 Cable and Lead Wire 트 Noise
- . 5.3.3 - Flex Life of Trunk Cable Flex Relief
- . 5.3.4 - Tensile Strength of Cable Connections
- I 5.3.5 - Number of Connector Mating/Unmating Cycles
- 트 5.3.6 - Connector Retention Force
- . 5.3.7 - Contact Resistance
- 트 5.3.9 - Dielectric Withstand Voltage
- IEC 60601-1:2005 3rd Edition standard 트
- = Part 8.5.2.3 Patient Leads
- Cable Mate
- Aux Device Compatibility
- Cable Flex Life
#### ■ Proposed Curbell device
- 트 ANSI/AAMI EC53:2013
- 5.3.2 Cable and Lead Wire . Noise
- . 5.3.3 - Flex Life of Trunk Cable Flex Relief
- . 5.3.4 - Tensile Strength of Cable Connections
- . 5.3.5 - Number of Connector Mating/Unmating Cycles
- I 5.3.6 - Connector Retention Force
- I 5.3.7 - Contact Resistance
- 5.3.9 Dielectric Withstand 트 Voltage
- IEC 60601-1:2005 3rd Edition standard .
- = Part 8.5.2.3 Patient Leads
- Cable Mate
- Aux Device Compatibility
- Cable Flex Life
- Current Curbell device (primary predicate)
- ANSI/AAMI EC53:2013
- 5.3.2 Cable and Lead Wire . Noise
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Image /page/7/Picture/2 description: The image shows the logo for Curbell Medical. The word "CURBELL" is written in a large, bold, blue font. Below the word "CURBELL" is the word "MEDICAL" in a smaller, green font. The logo is simple and professional.
- 5.3.3 - Flex Life of Trunk Cable Flex Relief
- 트 5.3.4 - Tensile Strength of Cable Connections
- 5.3.5 - Number of Connector Mating/Unmating Cycles
- I 5.3.6 - Connector Retention Force
- 5.3.7 Contact Resistance ■
- I 5.3.9 - Dielectric Withstand Voltage
- IEC 60601-1:2005 3rd Edition standard I
- . Part 8.5.2.3 Patient Leads
- Cable Mate I
- 트 Aux Device Compatibility
- I Cable Flex Life
- . Engineering Part Evaluation
- Proposed Curbell device ■
- I Verification of inspection to revision controlled drawings
- Inspection Report
- Proposed Curbell device ■
- 트 Dimensional inspection
- Biocompatibility (ISO 10993) .
- Proposed Curbell device 트
- I Wire Jacket Biocompatibility
- Overmold Biocompatibility
- I Connector Biocompatibility
- Curbell Design Inputs document: SPO2 Adapter Cable .
- Curbell Risk Analysis document: SPO2 Adapter Cable ●
- 10. Nonclinical performance data:
Curbell Patient Monitoring Cables have been assessed to the following performance standards and special controls:
- IEC 60601-1:2005, Section 8.5.2.3 - Patient Leads
- ANSI/AAMI EC53:2013 ECG Trunk Cables and Patient LeadWires
- 11. Clinical data: Not Applicable
- 12. Conclusion from nonclinical testing: The summary above illustrates that there are no different questions of safety or effectiveness of the proposed Curbell Patient Monitoring Cables compared to the current Curbell primary predicate device. Additionally, with respect to expanded use (SPO2 monitoring), the proposed Curbell
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Image /page/8/Picture/2 description: The image shows the logo for Curbell Medical. The word "CURBELL" is written in large, bold, blue letters. Below the word "CURBELL" is the word "MEDICAL" in smaller, green letters. The logo is simple and professional.
Patient Monitoring Cables device is substantially equivalent to the Curbell primary predicate device and the Shenzhen Med-link secondary predicate device.
