(68 days)
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.
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.
The provide document is a 510(k) summary for Curbell Patient Monitoring Cables. It asserts substantial equivalence to a predicate device (Merit Cables, Inc. K942321) rather than establishing novel performance criteria through a study. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance, is not directly applicable to this document.
However, based on the provided text, I can extract information related to how this device demonstrates equivalence for its intended use. The "acceptance criteria" here are effectively the performance characteristics and standards met by the predicate device, and the study is the nonclinical performance data demonstrating the Curbell device also meets these.
Here's an interpretation based on the provided document:
1. A table of acceptance criteria and the reported device performance
For this 510(k), the "acceptance criteria" are implied by the characteristics of the predicate device, and the "reported device performance" is the claim that the Curbell device possesses substantially equivalent characteristics.
| Acceptance Criteria (based on Predicate Device: Merit Industries, Inc. K942321 Characteristics) | Reported Device Performance (Curbell Patient Cables) |
|---|---|
| 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. | Substantially Equivalent: 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 | Substantially Equivalent: Reusable |
| 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. | Substantially Equivalent: 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 leadwire and shielded patient trunk cables with electrode connectors including snap, pinch, & Sure Lock. | Substantially Equivalent: Shielded and unshielded patient leadwires and shielded patient trunk cables with electrode connectors including snap, pinch, & Sure Lock. |
| Connectors: Electrode connectors - snap & pinch | Substantially Equivalent (with additional options): Electrode connectors - snap, pinch, & Sure Lock. (Note: Curbell offers "Sure Lock" in addition to the predicate's options, implying broader compatibility or an equivalent function). |
| Cable and lead wire length: Trunk Cable lengths include - 7 to 20 ft., Leadwire lengths from 18" to 120" | Within acceptable range/Substantially Equivalent: Trunk Cable lengths include - 10 ft; Leadwire lengths from 18" to 51" (Curbell's lengths fall within the predicate's reported range or are deemed equivalent for intended use). |
| Wire material: Shielded & Unshielded Copper with PVC or Polyurethane Jacket | Substantially Equivalent: Shielded & Unshielded Copper with Polyurethane Jacket (Polyurethane is a comparable material). |
| Sterility: Non Sterile | Substantially Equivalent: Non Sterile |
| Electrical performance testing: Per AAMI - EC 53 | Substantially Equivalent: 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 | Substantially Equivalent: • 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 | Substantially Equivalent: Per AAMI - EC 53 |
| Environmental safety: Cables are RoHS compliant | Substantially Equivalent: Cables are RoHS complainant (compliant). |
| Meets ANSI/AAMI standard: ANSI/AAMI EC53:1995 (revised 2001) | Substantially Equivalent: ANSI/AAMI EC53:1995 (revised 2001) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a "test set" in the context of data for an AI/ML device. Instead, the testing pertains to nonclinical performance data of the physical device. The provenance of the data is that it was generated through testing of Curbell Patient Monitoring Cables against established standards. No specific sample sizes for these tests are mentioned beyond the implication that sufficient samples were tested to demonstrate compliance with the referenced standards. The data is likely prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document is for a medical device (patient monitoring cables), not an AI/ML algorithm that requires expert ground truth labeling. Therefore, this information is not applicable. The "ground truth" for compliance testing is defined by the technical specifications and requirements of the referenced standards (e.g., AAMI EC 53).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of medical device submission. Adjudication methods are typically relevant for human interpretation of data where consensus among experts is needed for ground truth.
5. 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
Not applicable. This is not an AI/ML device, nor does it involve human readers interpreting data enhanced by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (cables and lead wires), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on the requirements and methodologies outlined in recognized national and international standards:
- 21 CFR 898
- IEC 60601-1, Subclause 56.3(c)
- ANSI/AAMI EC53:1995(R)2001
Compliance with these standards, as demonstrated through electrical, mechanical, and material testing, serves as the basis for asserting safety and effectiveness.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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.
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
-
- 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)
-
- 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 appropriatesites on the patient to a monitoring devicefor general monitoring and/or diagnosticevaluation by a healthcare professional. | Used to connect electrodes, catheters,and/or sensors placed at the appropriatesites on the patient to a monitoring devicefor general monitoring and/or diagnosticevaluation 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
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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.
| Anatomical site | Attached to sensors placed at specifiedlocations as required by the patientmonitor. Examples include Left arm,Right arm, Chest, Left leg & Right leg. | Attached to sensors placed at specifiedlocations as required by the patientmonitor. Examples include Left arm,Right arm, Chest, Left leg & Right leg. |
|---|---|---|
| Design | Shielded and unshielded patient leadwiresand shielded patient trunk cables withelectrode connectors including snap,pinch, & Sure Lock. | Shielded and unshielded patient leadwireand shielded patient trunk cables withelectrode connectors including snap,pinch, & Sure Lock. |
| Connectors | Electrode connectors - snap, pinch, &Sure Lock. | Electrode connectors - snap & pinch |
| Cable and leadwire length | Trunk Cable lengths include - 10 ftLeadwire lengths from 18" to 51" | Trunk Cable lengths include - 7 to 20 ft.,Leadwire lengths from 18" to 120" |
| Wire material | Shielded & Unshielded Copper withPolyurethane Jacket | Shielded & Unshielded Copper with PVCor Polyurethane Jacket |
| Sterility | Non Sterile | Non Sterile |
| Electricalperformancetesting | Per AAMI - EC 53 | Per AAMI - EC 53 |
| Electrical safetytesting | • Dielectric withstand per AAMI - EC 53• Insulation resistance per AAMI - EC53• Termination resistance per AAMI -EC 53 | • Dielectric withstand per AAMI - EC 53• Insulation resistance per AAMI - EC53• Termination resistance per AAMI -EC 53 |
| Connectorretention force | Per AAMI - EC 53 | Per AAMI - EC 53 |
| Environmentalsafety | Cables are RoHS complainant | Cables are RoHS compliant |
| Meets ANSI/AAMI standard | ANSI/AAMI EC53:1995 (revised 2001) | ANSI/AAMI EC53:1995 (revised 2001) |
-
- Nonclinical performance data:
Curbell Patient Monitoring Cables have been assessed to the following FDA performance standard and national and international standards:
- Nonclinical performance data:
-
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 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
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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.
| Anatomical site | Attached to sensors placed at specifiedlocations as required by the patientmonitor. Examples include Left arm,Right arm, Chest, Left leg & Right leg. | Attached to sensors placed at specifiedlocations as required by the patientmonitor. Examples include Left arm,Right arm, Chest, Left leg & Right leg. |
|---|---|---|
| Design | Shielded and unshielded patient leadwiresand shielded patient trunk cables withelectrode connectors including snap,pinch, & Sure Lock. | Shielded and unshielded patient leadwiresand shielded patient trunk cables withelectrode connectors including snap,pinch, & Sure Lock. |
| Connectors | Electrode connectors - snap, pinch, &Sure Lock. | Electrode connectors - snap & pinch |
| Cable and leadwire length | Trunk Cable lengths include - 10 ftLeadwire lengths from 18" to 51" | Trunk Cable lengths include - 7 to 20 ft.,Leadwire lengths from 18" to 120" |
| Wire material | Shielded & Unshielded Copper withPolyurethane Jacket | Shielded & Unshielded Copper with PVCor Polyurethane Jacket |
| Sterility | Non Sterile | Non Sterile |
| Electricalperformancetesting | Per AAMI - EC 53 | Per AAMI - EC 53 |
| Electrical safetytesting | • Dielectric withstand per AAMI - EC 53• Insulation resistance per AAMI - EC53• Termination resistance per AAMI -EC 53 | • Dielectric withstand per AAMI - EC 53• Insulation resistance per AAMI - EC53• Termination resistance per AAMI -EC 53 |
| Connectorretention force | Per AAMI - EC 53 | Per AAMI - EC 53 |
| Environmentalsafety | Cables are RoHS complainant | Cables are RoHS compliant |
| Meets ANSI/AAMI standard | ANSI/AAMI EC53:1995 (revised 2001) | ANSI/AAMI EC53:1995 (revised 2001) |
-
- Nonclinical performance data:
Curbell Patient Monitoring Cables have been assessed to the following FDA performance standard and national and international standards:
- Nonclinical performance data:
-
. 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.
Page 3 OF 3
Tal: 716.667.3377 Fax: 716.667.7508
20 Centre Drive Orchard Park, NY 14127
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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.
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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
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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
§ 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).