← Product Code [DSA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA) · K081762 # CURBELL PATIENT MONITORING CABLES (K081762) _Curbell Electronics, Inc. · DSA · Aug 27, 2008 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA/K081762 ## Device Facts - **Applicant:** Curbell Electronics, Inc. - **Product Code:** [DSA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA.md) - **Decision Date:** Aug 27, 2008 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 870.2900 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## 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 are reusable, shielded/unshielded leadwires and trunk cables; connect electrodes, sensors, or catheters placed on patient anatomical sites (e.g., chest, limbs) to patient monitoring devices. Used by healthcare professionals in clinical settings to facilitate signal transmission for general monitoring and diagnostic evaluation. Device acts as a physical interface between patient-applied sensors and monitoring equipment. Benefits include reliable signal connectivity for patient monitoring. No active processing or software components involved. ## Clinical Evidence No clinical data. ## Technological Characteristics Reusable shielded/unshielded copper cables with polyurethane jackets. Connectors include snap, pinch, and Sure Lock. Compliant with ANSI/AAMI EC53:1995(R)2001, IEC 60601-1 (Subclause 56.3(c)), and 21 CFR 898. Non-sterile. RoHS compliant. ## Regulatory 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 - Merit Cables, Inc. ([K942321](/device/K942321.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: 716-667-3377 x419 Fax:716-667-1390 Kevin Walls 2. Contact: Regulatory Insight, Inc. 5401 S. Cottonwood Ct. Greenwood Village, Colorado 80121 Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com 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: 716.667.3377 Fax: 716.667 7508 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: 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 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: 716.667.7508 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 (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. 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 Page 1 of 1 510(k) Number K081762 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA/K081762](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSA/K081762) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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