(29 days)
P950037/S8, K914109A, K923026C, K9141937
K914109A, K923026C, K9141937
No
The document describes a pacemaker with a feature for non-invasive programmed stimulation (NIPS), which is controlled by programmer software. There is no mention of AI or ML in the intended use, device description, or any of the other sections. The functionality described is based on pre-programmed stimulation protocols, not adaptive or learning algorithms.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The use of multi-programmable, single chamber pacemakers is indicated as a therapeutic modality for control of heart rate..." and lists various cardiac conditions for which the device is indicated.
Yes
The device performs a therapeutic function (pacing) but also includes a NIPS feature that allows it to perform a variety of cardiac electrophysiological (EP) studies, which are diagnostic in nature (e.g., assessing the heart's electrical activity and conduction pathways).
No
The device described is a feature (NIPS) for existing pulse generators (pacemakers). While the feature is enabled by unlocking software, it operates through the existing hardware (pulse generator and lead system) and is controlled by a programmer system. It is not a standalone software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is a pacemaker (pulse generator) and a feature (NIPS) that allows for cardiac electrophysiological (EP) studies. These are devices that are implanted in the body and interact directly with the heart's electrical system.
- No Mention of Samples: There is no mention of the device analyzing samples taken from the body.
- Focus on Electrical Activity: The device's function is described in terms of controlling heart rate and performing EP studies, which involve analyzing the electrical activity of the heart.
Therefore, the device described is a therapeutic and diagnostic device that operates in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
The indications/contraindications for use of the PIKOS products are identical to those for all single chamber (AAI or VVI) pulse generators.
The use of multi-programmable, single chamber pacemakers is indicated as a therapeutic modality for control of heart rate, provided that implantation is preceded by an adequate diagnostic check, and no parameter values dangerous for the patient are programmed. The use of the pacemaker in the atrium is contraindicated in the case of AV conduction disorder, and if atrial fibrillation or atrial flutter are exhibited. Ventricular pacing is not indicated in patients who already showed a pacemaker syndrome especially if a dual chamber pacemaker can be used.
Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following:
- Symptomatic paroxysmal or permanent second or third-degree AV block .
- Symptomatic bilateral bundle branch block .
- Symptomatic paroxysmal or transient sinus node dysfunctions with or without . associated AV conduction disorders
- . Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias
- Vasovagal syndromes or hypersensitive carotid sinus syndromes .
Product codes
74 WST; KRG, DXY
Device Description
BIOTRONIK requests clearance of the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's family of Pikos pulse generators. NIPS is provided as a feature in each of these pulse generators by allowing access to the NPS software drivers that were previously locked out. Each of these pulse generators has been FDA approved for use with P950037/S8, dated 08-24-99). The affected members of the Pikos family are comprised of the following pulse generators.
| Pulse Generator Name | Cleared | Feature Set | Lead Port |
|---|---|---|---|
| Pikos 01 | K914109A | Full | IS-1 |
| Pikos E01 | K914109A | Full | IS-1 |
| Pikos 01-A | K923026C | Full | 5-mm |
| Pikos E01-A | K923026C | Full | 5-mm |
| Pikos 01-B | K9141937 | Full | 6-mm |
| Pikos E01-B | K9141937 | Full | 6-mm |
Unlocking the NIPS feature within the programmer software allows a previously implanted pulse generator and lead system to invoke high rate pacing and perform a variety of cardiac electrophysiological (EP) studies.
The NIPS feature is generated entirely through the existing pulse generator and lead system. This feature is controlled by the programmer and activates the pulse generator only when the wand is placed directly over the device. There are no other external devices required for this system. The NIPS feature is approved for each pulse generator listed above outside the US, but has been blocked from the Pikos devices through BIOTRONIK's software lock. The NIPS feature will be unlocked for each member of the Pikos family with a release code to the B-HXX.0.U programmer software. BIOTRONIK will identify the software version as B-H02.0.U.
There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system to allow this feature. The primary functions of these pulse generators, th system and the B-H02.0.U software remain the same.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P950037/S8, K914109A, K923026C, K9141937
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 1 0 1999
BIOTRONIK, Inc., Pikos Family of Pulse Generators, NIPS Feature
Pikos Family of Pulse Generators Release of the NIPS Feature
SPECIAL 510(K) SUMMARY 1.
Name and Address of Sponsor:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number: 1028232
| Device Name:
Device Class: | Proprietary Names:
Classification:
Classification Name:
Product Code:
|
|-------------------------------|------------------------------------------------------------------------------------|
| Date Prepared: | October 7, 1999 |
| | Pikos
Class III
Implantable Pacemaker Pulse Generator
74 WST; KRG |
General Description
BIOTRONIK requests clearance of the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's family of Pikos pulse generators. NIPS is provided as a feature in each of these pulse generators by allowing access to the NPS software drivers that were previously locked out. Each of these
pulse generators has been FDA approved for use with P950037/S8, dated 08-24-99). The affected members of the Pikos family are comprised of the following pulse generators.
| Pulse Generator Name | Cleared | Feature Set | Lead Port |
|---|---|---|---|
| Pikos 01 | K914109A | Full | IS-1 |
| Pikos E01 | K914109A | Full | IS-1 |
| Pikos 01-A | K923026C | Full | 5-mm |
| Pikos E01-A | K923026C | Full | 5-mm |
| Pikos 01-B | K9141937 | Full | 6-mm |
| Pikos E01-B | K9141937 | Full | 6-mm |
Table 1
Unlocking the NIPS feature within the programmer software allows a previously implanted pulse generator and lead system to invoke high rate pacing and perform a variety of cardiac electrophysiological (EP) studies.
The NIPS feature is generated entirely through the existing pulse generator and lead system. This feature is controlled by the programmer and activates the pulse generator only when the wand is placed directly over the device. There are no other external devices required for this system. The NIPS feature is approved for each pulse generator listed above outside the US, but has been blocked from the Pikos devices through BIOTRONIK's software lock. The NIPS feature will be unlocked for each member of the Pikos family with a release code to the B-HXX.0.U programmer software. BIOTRONIK will identify the software version as B-H02.0.U.
There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system
to allow this feature. The primary functions of these pulse generators, th system and the B-H02.0.U software remain the same.
1
Indications for Use:
The indications/contraindications for use of the PIKOS products are identical to those for all single chamber (AAI or VVI) pulse generators.
The use of multi-programmable, single chamber pacemakers is indicated as a therapeutic modality for control of heart rate, provided that implantation is preceded by an adequate diagnostic check, and no parameter values dangerous for the patient are programmed. The use of the pacemaker in the atrium is contraindicated in the case of AV conduction disorder, and if atrial fibrillation or atrial flutter are exhibited. Ventricular pacing is not indicated in patients who already showed a pacemaker syndrome especially if a dual chamber pacemaker can be used.
Name and Address of Manufacturing Site: BIOTRONIK GmbH & Co. (rea. no. 7010992) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304
Contact Person(s) and Phone Number:
Jon Brumbaugh Director, Requlatory Affairs Phone (888) 345-0374 Fax (503) 635-9936
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 0 1999
Mr. Jon Brumbaugh Director, Requlatory Affairs Biotronik, Inc. 6024 Jean Road 97035 Lake Oswego, OR
K993434 Re: Implantable Pacemaker Pulse Generator Regulatory Class: III (three) Product Codes: DXY October 7, 1999 Dated: Received: October 12, 1999
Dear Mr. Brumbaugh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
Page 2 - Mr. Jon Brumbaugh
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Kla V. Tille
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number: K993434
Device Name: BIOTRONIK, Inc. Pikos single chamber pacemakers Models 01/01-A/E01/LP 01/LP E01/E01-B
Indications For Use:
Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following:
- Symptomatic paroxysmal or permanent second or third-degree AV block .
- Symptomatic bilateral bundle branch block .
- Symptomatic paroxysmal or transient sinus node dysfunctions with or without . associated AV conduction disorders
- . Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias
- Vasovagal syndromes or hypersensitive carotid sinus syndromes .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular, Respiratory, and Neurological Devices | ||
| 510(k) Number | K993434 |
Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1.2.96)
(Optional Format 1-2-96)