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.

AI/ML Overview

The provided text describes the regulatory clearance of "Curbell Patient Monitoring Cables" (K182220) and outlines the product's characteristics, intended use, and substantial equivalence to predicate devices. However, the text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, and compliance with recognized standards for biocompatibility, electrical performance, and electrical safety. It lists the standards that the device has been assessed against (e.g., ANSI/AAMI EC53:2013, IEC 60601-1:2005) and the types of tests performed (e.g., cable and lead wire noise, flex life, tensile strength, connector retention force, contact resistance, dielectric withstand voltage).

The submission is a 510(k) premarket notification, which is a regulatory pathway to demonstrate that a device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing the new device to existing ones rather than presenting novel clinical performance data or statistically robust performance studies with detailed acceptance criteria and ground truth establishment as outlined in your request.

Therefore, I cannot provide the requested information in the specified format because it is not present in the provided text.

Here's an explanation of why each point of your request cannot be fulfilled based on the given document:

A table of acceptance criteria and the reported device performance: While the document lists standards (e.g., ANSI/AAMI EC53:2013) that the device was assessed against, it does not provide specific numerical acceptance criteria (e.g., "noise must be less than X dB") nor the actual measured performance values of the Curbell Patient Monitoring Cables. It only states that the device "have been assessed to" these standards and that engineering verification and validation protocols have been used.
Sample size used for the test set and the data provenance: The document mentions "Engineering Verification and Validation Protocols" and "Inspection Report" but does not specify the sample sizes used for testing nor the provenance of any data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable and not provided for a device like patient monitoring cables. Ground truth relevant to expert opinion is typically associated with diagnostic or prognostic devices where clinical interpretation is paramount. For cables, performance is primarily assessed against engineering and safety standards.
Adjudication method for the test set: This is not applicable and not provided for the same reasons as point 3.
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: This is not applicable. The device is patient monitoring cables, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is patient monitoring cables, not an algorithm.
The type of ground truth used: For a device like patient monitoring cables, the "ground truth" is defined by compliance with established engineering and safety standards (e.g., electrical safety, biocompatibility, mechanical integrity like flex life and tensile strength). The document indicates assessment against these standards (IEC 60601-1, ANSI/AAMI EC53, ISO 10993). However, it does not explicitly detail how the "ground truth" for each specific test parameter was established beyond referencing these standards.
The sample size for the training set: This is not applicable as the device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: This is not applicable as the device is not an AI/ML algorithm.

Summary

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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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 DriveOrchard Park, NY 14127716-667-3377 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)]."

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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 CurbellPatients Cables	Current CurbellPatient Cables (PrimaryPredicate)	Shenzhen Med-link ElectronicsTech Co., Ltd.(Secondary Predicate – SPO2Monitoring)
510(k) Number	K182220	K081762	K120010
Intended use	Curbell patient cablesare used to connectelectrodes and/orsensors placed at theappropriate sites on thepatient to a monitoringdevice for generalmonitoring and/ordiagnostic evaluationby a healthcareprofessional.	Curbell patient cablesare used to connectelectrodes and/orsensors placed at theappropriate sites on thepatient to a monitoringdevice for generalmonitoring and/ordiagnostic evaluationby a healthcareprofessional.	The Shenzhen Med-link cablesand lead wires are intended tobe used with ECG, EKG, SPO2and Invasive Blood Pressuremonitoring devices. The patientcables and lead wires are usedto connect electrodes, catheters,and/or sensors placedat appropriate sites on thepatient to a monitoring devicefor general monitoring and/ordiagnostic evaluation by healthcare professional.
Regulation	21CFR870.2900	21CFR870.2900	21CFR870.2900
Product code	DSA	DSA	DSA
Common Name	Patient cables andleadwires	Patient cables andleadwires	Patient cables andleadwires
Proprietary Name	Curbell branded	Curbell branded	NA
Design/Materials	Shielded and unshieldedpatient leadwires andshielded patient trunkcables with electrodeconnectors includingsnap, pinch, or SureLock electrode clip.Trunk cable lengthsinclude - 7 to 20ft.Leadwire lengths from18" to 120". Wirematerial is comprised ofshielded and unshieldedcopper with PVC orthermoplasticpolyurethane jacket.	Shielded and unshieldedpatient leadwires andshielded patient trunkcables with electrodeconnectors includingsnap, pinch, or SureLock electrode clip.Trunk cable lengthsinclude - 7 to 20ft.Leadwire lengths from18" to 120". Wirematerial is comprised ofshielded and unshieldedcopper with PVC orthermoplasticpolyurethane jacket.	ECG and EKG Cables withvarious connectors (monitor,trunk/lead wire, electrodegrabber & snapper). SPO2adapter cables withvarious connectors for connectfor the OEM Instrumentconnector of SPO2 monitor andSPO2 probe.Cable is set at various specifiedstandard lengths.Wire material is comprised ofshielded and unshielded copperwith PVC or thermoplasticpolyurethane 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 10993-5Cytotoxicity,ISO 10993-10Sensitization, andISO 10993-10 Irritation.	Meets ISO 10993-5Cytotoxicity,ISO 10993-10Sensitization, andISO 10993-10 Irritation	Meets ISO 10993-5Cytotoxicity,ISO 10993-10 Sensitization,andISO 10993-10 Irritation
Sterility	Non sterile	Non sterile	Non sterile
Electricalperformancetesting	ANSI/AAMI EC53:2013	ANSI/AAMI EC53:1995 (revised 2001)	ANSI/AAMI EC53:1995(revised 2001)
Electrical Safetytesting	ANSI/AAMI EC53:2013, IEC 60601-1:2005, 3rd Editionstandard - Part 8.5.2.3Patient Leads	ANSI/AAMI EC53:1995 (revised 2001)	ANSI/AAMI EC53:1995(revised 2001), IEC 60601-1:1998;Am1, A2:1995
ConnectorRetention Force	ANSI/AAMI EC53:2013	ANSI/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.

Regulation Number and Section

§ 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).