(55 days)
Fastlock pacing wire extension cable with connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes.
The Fastlock pacing wire extension cable device provides simple connection between an external pacemaker and pacing wires that are attached to a patient body, in order to transmit low voltage electrical signals between the devices and sensors. The Fastlock product is limited by the Indications for Use of the connected external pacemaker.
This document is a 510(k) summary for a medical device called "Fastlock Pacing Wire Extension Cable". It outlines the device's purpose, characteristics, and comparison to a predicate device to establish substantial equivalence for regulatory approval.
Here's an analysis of the provided text with respect to your questions:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not contain explicit acceptance criteria or reported device performance data in the way you would expect from a study report. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific numerical benchmarks.
The "Summary of Technical Characteristics" table compares features of the Fastlock Extension Cable with the Predicate Device:
| Feature | FastLock Extension Cable | Disposable Temporary Pacing Cable (Predicate) |
|---|---|---|
| Classification # &Product Code | 870.2900DSA | 870.2900DSA |
| Intended Use | interface betweenexternal pacemaker andpacing wires, which areattached to a patientbody. | Interface between variousdiagnostic andphysiological monitoringdevices (not manufacturedby CP Medical) anddisposable sensordevices(not manufacturedby CP Medical) which areattached to a patient body. |
| Mode of Action | Connects to pacemaker | Connects to pacemaker |
| Reusable | No | No |
| Method of ClampIntroduction | Male to female connector | Alligator clips |
Reported Device Performance (Implicit):
The "Conclusion" states: "The information discussed above demonstrates that Fastlock product, as effective, and performs as well as or better than the predicate devices." This is a qualitative statement of performance equivalence, not a quantitative report. The key 'performance' aspects demonstrated here are the shared Intended Use, Mode of Action, and non-reusability with the predicate device, suggesting it functions similarly without introducing new safety or effectiveness concerns. The difference in "Method of Clamp Introduction" (male to female connector vs. alligator clips) is a design characteristic, not a performance metric that would have a numerical "reported performance" value in this context.
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 mention any specific test set, sample size, or data provenance (country of origin, retrospective/prospective) for a study of the Fastlock cable's performance. 510(k) submissions for devices like this often rely on demonstrating that the new device meets recognized standards (e.g., electrical safety, biocompatibility) and is functionally equivalent to an existing device, rather than extensive clinical efficacy studies with patient data.
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 information is not applicable and not provided. This type of information is relevant for studies involving subjective interpretation of medical images or complex diagnostic algorithms. The Fastlock Pacing Wire Extension Cable is a simple electrical connector; its performance is evaluated based on objective engineering standards and functional equivalence, not expert interpretation of data it generates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in studies where there is subjective assessment or disagreement among experts, typically in diagnostic or imaging contexts. This device does not involve such a process.
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
This information is not applicable and not provided. MRMC studies and "human readers improve with AI vs without AI assistance" are relevant for AI-powered diagnostic or decision support systems. The Fastlock Pacing Wire Extension Cable is a passive electrical component with no AI capabilities or role in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. "Standalone algorithm performance" is relevant for AI or automated diagnostic algorithms. The Fastlock Pacing Wire Extension Cable is a hardware component and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied in diagnostic or AI studies (e.g., pathology for cancer detection, outcomes data for treatment efficacy) is not directly applicable to this device. For this type of device, the "truth" is established by adherence to engineering specifications for electrical conductivity, insulation, biocompatibility, and functional compatibility with intended connecting devices (pacemakers and pacing wires). Validation would typically involve:
- Bench testing: Measuring electrical properties, mechanical strength, and material integrity.
- Compliance with standards: Demonstrating adherence to relevant international or national standards for medical electrical equipment (e.g., ISO, IEC).
- Functional testing: Ensuring it correctly transmits signals between a pacemaker and pacing wires in a controlled environment.
This document does not detail specific ground truth establishment methods but implies that the device meets safety and performance expectations through its similarity to the predicate and likely adherence to general controls and recognized standards.
8. The sample size for the training set
This information is not applicable and not provided. Training sets are used for machine learning models. The Fastlock Pacing Wire Extension Cable is a physical medical device, not an algorithm, so it does not have a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, for the same reasons as #8.
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FastLock Premarket Notification: Traditional 510(k)
510(k) Summary
APR 2 9 2008
| Submitter Name:Submitter Address: | European Custom Manufacturing B.V.PO Box 53, NL 5420 AB Gemert, The Netherlands |
|---|---|
| Phone Number: | 31-492-371234 |
| Fax Number: | 31-492-371237 |
| Contact Person: | Rogier Eijck |
| Date Prepared: | 29 November 2007 |
| Device Trade Name: | Fastlock Pacing Wire Extension Cable |
| Common Name | ECG Cables |
| Classification Name,Number &Product Code: | Cable, transducer and electrode, patient (including connector)870.2900DSA |
| Predicate Devices: | CP Medical Disposable Temporary Pacing Cable |
| Device Descriptionand Statement ofIntended Use | The Fastlock pacing wire extension cable device provides simpleconnection between an external pacemaker and pacing wires that areattached to a patient body, in order to transmit low voltage electricalsignals between the devices and sensors. The Fastlock product islimited by the Indications for Use of the connected external pacemaker.Intended Use: The Fastlock pacing wire extension cable device isintended to be used as an interface between an external pacemaker andpacing wires, which are attached to a patient body. |
| Summary ofTechnologicalCharacteristics | The Fastlock pacing wire extension cable consists of an electrical cablewith a safety connector at one end that allows electrical connection tothe external pacemaker and connectors at the other end that will beattached to the patient's leads. |
| Conclusion | The information discussed above demonstrates that Fastlock product, aseffective, and performs as well as or better than the predicate devices. |
| Declarations | This summary includes only information that is also covered in the bodyof the 510(k).This summary does not contain any puffery or unsubstantiated labelingclaims. |
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This summary does not contain any raw data, i.e., contains only summary data.
This summary does not contain any trade secret or confidential commercial information.
This summary does not contain any patient identification information.
K080421 Page 2 of 3
Section 5.0: 510(k) Summary
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| Feature | FastLock ExtensionCable | Disposable TemporaryPacing Cable |
|---|---|---|
| 510(k) Number | K022075 | |
| Manufacturer | European CustomManufacturing BV | CP Medical, Inc. |
| Classification # &Product Code | 870.2900DSA | 870.2900DSA |
| Intended Use | interface betweenexternal pacemaker andpacing wires, which areattached to a patientbody. | Interface between variousdiagnostic andphysiological monitoringdevices (not manufacturedby CP Medical) anddisposable sensordevices(not manufacturedby CP Medical) which areattached to a patient body. |
| Mode of Action | Connects to pacemaker | Connects to pacemaker |
| Reusable | No | No |
| Method of ClampIntroduction | Male to female connector | Alligator clips |
Summary of Technical Characteristics
K080621 page 3 of 3
Section 5.0: 510(k) Summary
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2008
European Custom Manufacturing BV c/o Mr. William Greenrose President Oserve America, Inc. 220 River Road Claremont, NH 03743
Re: K080621
Trade/Device Name: Fastlock Regulation Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable Regulatory Class: Class II (two) Product Code: DSA Dated: December 13, 2007 Received: March 5, 2008
Dear Mr. Greenrose:
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. 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. William Greenrose
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Blymmmofa
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): K080621
Device Name: Fastlock
Indications For Use:
Fastlock pacing wire extension cable with connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummenauer
§ 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).