(474 days)
The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions:
- · Sinus node arrest or bradycardia with or without AV conduction disorder.
- · Intermittent or complete AV conduction block.
- · Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia.
- · Atrial fibrillation and ventricular bradyarrhythmia.
The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator which is designed and recommended for use with atrial or ventricular leads. The Pikos LP 01/LP E01 models offer a limited number of programmable options compared to those of the Pikos 01/E01 models.
This 510(k) submission (K945627) for the Pikos LP 01/LP B01 Implantable Pacemaker Pulse Generators focuses on demonstrating substantial equivalence to a predicate device (K914109/A, Pikos 01 and Pikos H01) rather than establishing new acceptance criteria through a clinical study. Therefore, most of the requested information regarding a study proving acceptance criteria will not be present.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define a table of new acceptance criteria and corresponding performance metrics from a distinct study for this device. Instead, it relies on demonstrating that the new device performs equivalently to a predicate device (Pikos 01/E01 models) based on pre-established performance of that predicate.
The qualification testing mentioned is primarily for design verification and validation of components and modifications, not for proving clinical performance against new acceptance criteria.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: | The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator designed for use with atrial or ventricular leads, similar to the Pikos 01/E01 models. |
| Intended Use Equivalence: | "The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions: Sinus node arrest or bradycardia with or without AV conduction disorder. Intermittent or complete AV conduction block. Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia. Atrial fibrillation and ventricular bradyarrhythmia." The intended uses are identical to the predicate device. |
| Design/Component Qualification (Modifications): | - Battery Qualification: "identical to that submitted in the Pikos 01/501 premarket notification (K914109/A)." (i.e., meets prior acceptance criteria).- Self-Sealing Header: "qualification reports describing the testing conducted for validation... included vibration, shock, temperature and transport tests meeting the applicable IS-1 requirements; header leakage resistance tests. Sterilization... was validated."- Hybrid Circuit Modifications: "qualified with complete electrical and mechanical testing." (Implies meeting internal design specifications and performance standards). |
| Safety and Effectiveness: | "The product labeling includes instructions for use adequate to assure safe and effective operation of the device." (Relies on the established safety and effectiveness of the predicate device and verification of modifications). |
2. Sample Size Used for the Test Set and the Data Provenance
No specific "test set" in the context of clinical data for proving new acceptance criteria is described. The "qualification testing" refers to engineering and bench testing.
- Sample Size: Not applicable in the context of a clinical test set from human subjects for this submission. The "sample" likely refers to components or finished devices subjected to various engineering tests (e.g., a certain number of self-sealing headers tested for leakage). These numbers are not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data. The qualification testing data would be generated in-house by BIOTRONIK GmbH & Co.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission is for a medical device that relies on engineering qualification and demonstrated equivalence, not a diagnostic algorithm requiring expert-established ground truth from a test set of human data.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
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-assisted diagnostic device, and no MRMC study or AI components are mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable for the reasons stated above.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the qualification testing of components and modifications (e.g., self-sealing header, hybrid circuits), the "ground truth" would be engineering specifications, international standards (like IS-1 mentioned for the header), and internal design requirements.
For the substantial equivalence claim, the "ground truth" is effectively the established safety and effectiveness profile and performance characteristics of the predicate device (Pikos 01/E01).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
In summary: This 510(k) submission is for an implantable pacemaker pulse generator that relies on demonstrating substantial equivalence to an already approved predicate device. The "qualification testing" described is for verifying the design and manufacturing of the new device and any modifications, ensuring it meets engineering standards and is comparable to the predicate. It does not involve a clinical study with human subjects designed to establish new performance acceptance criteria for a novel device.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS V.
GENERAL INFORMATION
Device Name: Proprietary Name Pikos LP 01, Pikos LP B01 Implantable Pacemaker Pulse Generators Classification Name Class III (21 CFR 870.3610) Device Classification: BIOTRONIK GmbH & Co. Mamfacturer: Woermannkehre 1 D-12359 Berlin Germany Registration No .: 7010992 BIOTRONIK, Inc. Applicant's Name & Address: 6024 Jean Road Lake Oswego. OR 97035 1028232 Establishment Registration No .: No applicable performance standards have been Performance Standards: promulgated for these devices.
DESCRIPTION OF DEVICE
The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator which is designed and recommended for use with atrial or ventricular leads. The Pikos LP 01/LP E01 models offer a limited number of programmable options compared to those of the Pikos 01/E01 models.
SUBSTANTIAL EQUIVALENCE
The Pikos LP 01/LP B01 pulse generators are substantially equivalent to the currently marketed Pikos 01 and Pikos H01 respectively (K914109/A, approved February 26, 1992). Data to support this statement is provided in the premarket notification.
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INTENDED USE
The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions:
- · Sinus node arrest or bradycardia with or without AV conduction disorder.
- · Intermittent or complete AV conduction block.
- · Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia.
- · Atrial fibrillation and ventricular bradyarrhythmia.
QUALIFICATION TESTING
Qualification testing for the Pikos LP 01/LP B01 models is provided in this submission with the exception of battery qualification data which is identical to that submitted in the Pikos 01/501 premarket notification (K914109/A). Qualification reports describing the testing conducted for validation of the self-sealing header are included in this submission. The qualification of the self-sealing header included vibration, shock, temperature and transport tests meeting the applicable IS-1 requirements; header leakage resistance tests. Sterilization of the self-sealing header was validated. Hybrid circuit modifications were qualified with complete electrical and mechanical testing.
LABELING
Proposed labeling for the Pikos LP 01/LP E01 models is included in the premarket notification. The product labeling includes instructions for use adequate to assure safe and effective operation of the device.
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Public Health Service
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'APR 2 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc 6024 Jean Road Lake Oswego, OR 97035
Re: K945627
Trade/Device Name: Pikos LP 01 and Pikos LP E 01 Pacemakers Regulation Number: 21 CRF 870.3610 Regulation Name: Implantable pacemaker pulse generator Regulatory Class: III (three) Product Code: 74 DXY Dated: November 22, 1995 Received: November 24, 1995
Dear Mr. Brumbaugh:
This letter corrects our substantially equivalent letter of March 5, 1995.
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 (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 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. Jon Brumbaugh
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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
§ 870.3610 Implantable pacemaker pulse generator.
(a)
Identification. An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.(b)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 20, 2012, for any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or that has, on or before September 20, 2012, been found to be substantially equivalent to any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976. Any other implantable pacemaker pulse generator device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.