K Number
K182220
Device Name
Curbell branded Patient Monitoring Cables
Date Cleared
2018-11-07

(84 days)

Product Code
Regulation Number
870.2900
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
Device Description
Curbell Patient Monitoring Cables comprise cables and lead 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.
More Information

Not Found

No
The device description and intended use clearly state that the device is a cable used to connect sensors to a monitor. There is no mention of any processing or analysis of data using AI or ML. The performance studies focus on electrical and cable standards, not algorithmic performance.

No.
The device is used to connect electrodes/sensors to a monitoring device for diagnostic evaluation and monitoring, not for providing therapy.

Yes
The device description states its purpose is for "conducting ECG diagnosis, monitoring, and SPO2 monitoring," which includes diagnostic evaluation.

No

The device description explicitly states it comprises "cables and lead wires," which are physical hardware components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the cables are used to connect electrodes and/or sensors placed on the patient to a monitoring device. This indicates the device is used for monitoring physiological signals from the patient's body.
  • Device Description: The description reinforces this by mentioning connecting sensors and electrodes to a monitor for ECG and SpO2 monitoring. These are measurements taken directly from the patient.
  • Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body, which is the defining characteristic of an in vitro diagnostic device.

IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a cable used to transmit signals from sensors attached to the patient's body to a monitoring device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DSA

Device Description

Curbell Patient Monitoring Cables comprise cables and lead 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.

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

healthcare professional.

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)

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
    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 Patient Monitoring Cables device is substantially equivalent to the Curbell primary predicate device and the Shenzhen Med-link secondary 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.

K081762, K120010

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 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

1

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

2

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.
20 Centre Drive
Orchard Park, NY 14127
716-667-3377 x419 |

----------------------------------------------------------------------------------------------------------------
    1. Contact: Michael Winter
    1. Date Prepared: October 10, 2018
    1. Trade Name: Curbell Patient Monitoring Cables
    1. 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
    1. 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.
    1. 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.
    1. 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)]."

4

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
Patients Cables | Current Curbell
Patient Cables (Primary
Predicate) | Shenzhen Med-link Electronics
Tech Co., Ltd.
(Secondary Predicate – SPO2
Monitoring) |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182220 | K081762 | K120010 |
| 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. | 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. | The Shenzhen Med-link cables
and lead wires are intended to
be used with ECG, EKG, SPO2
and Invasive Blood Pressure
monitoring devices. The patient
cables and lead wires are used
to connect electrodes, catheters,
and/or sensors placed
at appropriate sites on the
patient to a monitoring device
for general monitoring and/or
diagnostic evaluation by health
care professional. |
| Regulation | 21CFR870.2900 | 21CFR870.2900 | 21CFR870.2900 |
| Product code | DSA | DSA | DSA |
| Common Name | Patient cables and
leadwires | Patient cables and
leadwires | Patient cables and
leadwires |
| Proprietary Name | Curbell branded | Curbell branded | NA |
| Design/Materials | Shielded and unshielded
patient leadwires and
shielded patient trunk
cables with electrode
connectors including
snap, pinch, or Sure
Lock electrode clip.
Trunk cable lengths
include - 7 to 20ft.
Leadwire lengths from
18" to 120". Wire
material is comprised of
shielded and unshielded
copper with PVC or
thermoplastic
polyurethane jacket. | Shielded and unshielded
patient leadwires and
shielded patient trunk
cables with electrode
connectors including
snap, pinch, or Sure
Lock electrode clip.
Trunk cable lengths
include - 7 to 20ft.
Leadwire lengths from
18" to 120". Wire
material is comprised of
shielded and unshielded
copper with PVC or
thermoplastic
polyurethane jacket. | ECG and EKG Cables with
various connectors (monitor,
trunk/lead wire, electrode
grabber & snapper). SPO2
adapter cables with
various connectors for connect
for the OEM Instrument
connector of SPO2 monitor and
SPO2 probe.
Cable is set at various specified
standard lengths.
Wire material is comprised of
shielded and unshielded copper
with PVC or thermoplastic
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
BiocompatibilityMeets ISO 10993-5
Cytotoxicity,
ISO 10993-10
Sensitization, and
ISO 10993-10 Irritation.Meets ISO 10993-5
Cytotoxicity,
ISO 10993-10
Sensitization, and
ISO 10993-10 IrritationMeets ISO 10993-5
Cytotoxicity,
ISO 10993-10 Sensitization,
and
ISO 10993-10 Irritation
SterilityNon sterileNon sterileNon sterile
Electrical
performance
testingANSI/AAMI EC53:
2013ANSI/AAMI EC53:
1995 (revised 2001)ANSI/AAMI EC53:1995
(revised 2001)
Electrical Safety
testingANSI/AAMI EC53:
2013, IEC 60601-1:
2005, 3rd Edition
standard - Part 8.5.2.3
Patient LeadsANSI/AAMI EC53:
1995 (revised 2001)ANSI/AAMI EC53:1995
(revised 2001), IEC 60601-
1:1998;Am1, A2:1995
Connector
Retention ForceANSI/AAMI EC53:
2013ANSI/AAMI EC53:
1995 (revised 2001)ANSI/AAMI EC53:1995
(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 ●
    1. 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
    1. Clinical data: Not Applicable
    1. 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.