CURBELL PATIENT MONITORING CABLES

• K Number: K081762
• Device Name: CURBELL PATIENT MONITORING CABLES
• Manufacturer: CURBELL ELECTRONICS INC.
• Date Cleared: 2008-08-27 ( 68 days)
• Product Code: DSA
• Regulation Number: 870.2900

Intended Use

Curbell patient cables are used to connect electrodes and/or sensors placed at the appro priate sites on the patient to a monitoring device for general monitoring and/or diagno stic evaluation by a healthcare professional.

Device Description

Curbell Patient Monitoring Cables and Lead Wires. 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.

Predicate Devices

K942321

Reference Devices

K942321

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical connection and electrical safety of cables, with no mention of data processing, algorithms, or AI/ML terms.

Therapeutic

No.
The device is described as connecting electrodes and/or sensors to a monitoring device for general monitoring and/or diagnostic evaluation, indicating its role in data collection and assessment, not direct therapeutic intervention.

Diagnostic

No
Explanation: The device is a patient cable used to connect electrodes/sensors to a monitoring device. It is not the monitoring device itself, nor does it perform any diagnostic evaluation. Its function is to facilitate the connection for a monitoring device that may be used for diagnostic evaluation.

SaMD (Software as a Medical Device)

No

The device description explicitly states "Curbell Patient Monitoring Cables and Lead Wires," indicating a physical hardware component used to connect electrodes and sensors. The performance studies also focus on nonclinical testing of these cables against relevant standards.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use describes the cables as connecting electrodes and sensors on the patient to a monitoring device for general monitoring and/or diagnostic evaluation. This involves collecting physiological signals from the patient's body.
• Device Description: The description reinforces that the cables connect sensors placed on the patient.
• Anatomical Site: The anatomical sites listed are locations on the patient's body (arms, chest, legs).
• Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not process or analyze such specimens.

The device is a component used in a system for in vivo (within the body) monitoring and diagnostic evaluation, not in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

DSA

Device Description

Curbell Patient Monitoring Cables and Lead Wires. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Attached to sensors placed at specified locations as required by the patient monitor. Examples include Left arm, Right arm, Chest, Left leg & Right leg.

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

Nonclinical performance data: Curbell Patient Monitoring Cables have been assessed to the following FDA performance standard and national and international standards:
. 21 CFR 898
. IEC 60601-1, Subclause 56.3(c)
. ANSI/AAMI EC53:1995(R)2001
Clinical data: None

Conclusion from nonclinical testing: The summary above illustrates that there are no new questions or differences in the safety and effectiveness of the Curbell Patient Monitoring Cables to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

Merit Cables, Inc. 510(k) K942321

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the word "CURBELL" in a bold, sans-serif font. The word is black and appears to be slightly pixelated. Below the word, there are several diagonal lines that are also black. The lines are of varying lengths and are spaced apart from each other.

K081762

510(k) Summary

Curbell Electronics, Inc. www.camelelectronics.com

Curbell Electronics, Inc. 1. Company: 20 Centre Drive Orchard Park, NY 14127 Telephone: [phone] x419 Fax:[phone]

Kevin Walls 2. Contact: Regulatory Insight, Inc. 5401 S. Cottonwood Ct. Greenwood Village, Colorado 80121 Telephone: [phone] Fax: [phone] Email: [e-mail]

AUG 2 7 2008

• 3. Date Prepared: June 18, 2008
• Curbell Patient Monitoring Cables Trade Name: 4.
• Patient Monitoring Cables 5. Common Name:
• Patient Transducer and Electrode Cable (including connector) Classification Name: હ. (21CFR870.2900, Product Code DSA)
• 7. Predicate device: Merit Cables, Inc. 510(k) K942321
• Curbell Patient Monitoring Cables and Lead Wires. 8. Device description:
• Curbell patient cables are used to connect electrodes and/or sensors Indications for Use: 9. 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 Monitoring Cables are 10. Technological characteristics to predicate device: substantially equivalent in safety and effectives to the predicate device, Merit Industries, Inc. (K942321), as demonstrated in the following table:

	Curbell Patient Cables	Merit Industries, Inc.
510(k) number	N/A	K942321
Intended use	Used to connect electrodes, catheters,
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.	Used to connect electrodes, catheters,
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.
Usage	Reusable	Reusable

Tel: [phone] Fax: [phone]

Page 1 OF 3

20 Centre Drive Orchard Park, NY 14127

1

Image /page/1/Picture/1 description: The image contains the word "CURBELL" in a bold, sans-serif font. The word is positioned at the top of the image. Below the word, there are several diagonal lines that are oriented from the bottom left to the top right. The lines are evenly spaced and appear to be part of the logo or design associated with the word "CURBELL".

Curbell Electronics, Inc.

www.curbellelectronics.com

| Anatomical site | Attached to sensors placed at specified
locations as required by the patient
monitor. Examples include Left arm,
Right arm, Chest, Left leg & Right leg. | Attached to sensors placed at specified
locations as required by the patient
monitor. Examples include Left arm,
Right arm, Chest, Left leg & Right leg. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Shielded and unshielded patient leadwires
and shielded patient trunk cables with
electrode connectors including snap,
pinch, & Sure Lock. | Shielded and unshielded patient leadwire
and shielded patient trunk cables with
electrode connectors including snap,
pinch, & Sure Lock. |
| Connectors | Electrode connectors - snap, pinch, &
Sure Lock. | Electrode connectors - snap & pinch |
| Cable and lead
wire length | Trunk Cable lengths include - 10 ft
Leadwire lengths from 18" to 51" | Trunk Cable lengths include - 7 to 20 ft.,
Leadwire lengths from 18" to 120" |
| Wire material | Shielded & Unshielded Copper with
Polyurethane Jacket | Shielded & Unshielded Copper with PVC
or Polyurethane Jacket |
| Sterility | Non Sterile | Non Sterile |
| Electrical
performance
testing | Per AAMI - EC 53 | Per AAMI - EC 53 |
| Electrical safety
testing | • Dielectric withstand per AAMI - EC 53
• Insulation resistance per AAMI - EC
53
• Termination resistance per AAMI -
EC 53 | • Dielectric withstand per AAMI - EC 53
• Insulation resistance per AAMI - EC
53
• Termination resistance per AAMI -
EC 53 |
| Connector
retention force | Per AAMI - EC 53 | Per AAMI - EC 53 |
| Environmental
safety | Cables are RoHS complainant | Cables are RoHS compliant |
| Meets ANSI/
AAMI standard | ANSI/AAMI EC53:1995 (revised 2001) | ANSI/AAMI EC53:1995 (revised 2001) |

• 11. Nonclinical performance data:
      Curbell Patient Monitoring Cables have been assessed to the following FDA performance standard and national and international standards:

• 21 CFR 898 .

• IEC 60601-1, Subclause 56.3(c) .

• ANSI/AAMI EC53:1995(R)2001 .

• 12. Clinical data: None

• Conclusion from nonclinical testing: The summary above illustrates that there are no new 13. questions or differences in the safety and effectiveness of the Curbell Patient Monitoring Cables to the predicate device.

Page 2 OF 3

Tel: [phone] Fax: [phone]

20 Centre Drive Orchard Park, NY 14127

2

Image /page/2/Picture/1 description: The image shows the word "CURBELL" in a bold, sans-serif font. The word is slightly angled upwards from left to right. Below the word, there are five thick, diagonal lines that are also angled upwards from left to right. The lines are evenly spaced and create a sense of movement or direction.

Curbell Electronics, Inc.

www.curbeilerectron-b5.com

| Anatomical site | Attached to sensors placed at specified
locations as required by the patient
monitor. Examples include Left arm,
Right arm, Chest, Left leg & Right leg. | Attached to sensors placed at specified
locations as required by the patient
monitor. Examples include Left arm,
Right arm, Chest, Left leg & Right leg. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Shielded and unshielded patient leadwires
and shielded patient trunk cables with
electrode connectors including snap,
pinch, & Sure Lock. | Shielded and unshielded patient leadwires
and shielded patient trunk cables with
electrode connectors including snap,
pinch, & Sure Lock. |
| Connectors | Electrode connectors - snap, pinch, &
Sure Lock. | Electrode connectors - snap & pinch |
| Cable and lead
wire length | Trunk Cable lengths include - 10 ft
Leadwire lengths from 18" to 51" | Trunk Cable lengths include - 7 to 20 ft.,
Leadwire lengths from 18" to 120" |
| Wire material | Shielded & Unshielded Copper with
Polyurethane Jacket | Shielded & Unshielded Copper with PVC
or Polyurethane Jacket |
| Sterility | Non Sterile | Non Sterile |
| Electrical
performance
testing | Per AAMI - EC 53 | Per AAMI - EC 53 |
| Electrical safety
testing | • Dielectric withstand per AAMI - EC 53
• Insulation resistance per AAMI - EC
53
• Termination resistance per AAMI -
EC 53 | • Dielectric withstand per AAMI - EC 53
• Insulation resistance per AAMI - EC
53
• Termination resistance per AAMI -
EC 53 |
| Connector
retention force | Per AAMI - EC 53 | Per AAMI - EC 53 |
| Environmental
safety | Cables are RoHS complainant | Cables are RoHS compliant |
| Meets ANSI/
AAMI standard | ANSI/AAMI EC53:1995 (revised 2001) | ANSI/AAMI EC53:1995 (revised 2001) |

• 11. Nonclinical performance data:
      Curbell Patient Monitoring Cables have been assessed to the following FDA performance standard and national and international standards:

• . 21 CFR 898

• . IEC 60601-1, Subclause 56.3(c)

• ANSI/AAMI EC53:1995(R)2001 .

• 12. Clinical data: None
• 13. Conclusion from nonclinical testing: The summary above illustrates that there are no new questions or differences in the safety and effectiveness of the Curbell Patient Monitoring Cables to the predicate device.

Page 3 OF 3

Tal: 716.667.3377 Fax: [phone]

20 Centre Drive Orchard Park, NY 14127

3

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Curbell Electronics, Inc. c/o Mr. Kevin Walls Regulatory Insight Inc. 5401 S. Cottonwood Ct. Greenwood Village, CO 80121

AUG 2 7 2008

Re: K081762

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 (two) Product Code: DSA Dated: August 18, 2008 Received: August 21, 2008

Dear Mr. Walls:

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, Trug, 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.

4

Page 2 - Mr. Kevin Walls

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 Section 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Olmall

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number (if known): KOS/ 762

Device Names: Curbell Patient Monitoring Cables

Indications for Use: Curbell patient cables are used to connect electrodes and/or sensors placed at the appro priate sites on the patient to a monitoring device for general monitoring and/or diagno stic evaluation by a healthcare professional.

Prescription Use X Over-The-Counter Us e AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

hm

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number K081762