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 .

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.

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.

AI/ML Overview

The provided text does not contain detailed information regarding acceptance criteria, device performance metrics, or study designs typically used to prove that a device meets specific acceptance criteria in the context of device performance. This document is a 510(k) submission summary for the NIPS (Non-Invasive Programmed Stimulation) feature for BIOTRONIK's Pikos family of pulse generators, focusing on regulatory clearance based on substantial equivalence.

The core of the submission is that the NIPS feature is being "unlocked" from existing, previously FDA-approved pulse generators (Pikos family) and utilizes existing hardware and software drivers. The clearance is based on the premise that there are no hardware changes to the pulse generators or programmer system, and the primary functions remain the same. Therefore, the regulatory decision appears to be based on the substantial equivalence to the previously cleared devices rather than a new performance study with specific acceptance criteria as one might find for a novel device or feature requiring extensive clinical validation.

Without direct information from the text, I cannot complete the requested tables and descriptions. Many of the requested fields (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth establishment, training set details) are relevant to studies demonstrating new device efficacy or accuracy, which does not appear to be the focus of this 510(k) submission.

However, based on the information provided, here's what can be inferred or stated about the "acceptance criteria" and "study" in a regulatory context:

Implied Acceptance Criteria (Regulatory):

The implied acceptance criteria for this 510(k) submission relate to the device's safety and effectiveness compared to a predicate device, as per FDA's substantial equivalence pathway.

Safety: The NIPS feature, when unlocked, does not introduce new safety risks compared to the predicate devices. This is supported by the statement that "There are no hardware changes to any of the pulse generators or the EPR 1000"-10 programmer system to allow this feature" and that the "primary functions... remain the same."
Effectiveness (Functional Equivalence): The NIPS feature performs its intended function (high rate pacing and EP studies) in a manner equivalent to how it would perform on previously approved devices or off-label use, or devices cleared outside the US. The fact that it's an "unlocked" feature using existing software drivers suggests its fundamental functionality is already established within the existing hardware.
No New Indications/Contraindications: The indications/contraindications for use of the PIKOS products with the NIPS feature remain "identical to those for all single chamber (AAI or VVI) pulse generators." This implies no new therapeutic claims are being made that would require novel performance data.

The "Study" (Regulatory Review Process):

The "study" or review that proves the device meets these implied acceptance criteria is the FDA 510(k) Pre-market Notification Review Process.

This process involves:

Documentation Review: BIOTRONIK submitted documentation (the 510(k) itself) outlining the device description, its intended use, technological characteristics, and comparison to predicate devices.
Predicate Device Comparison: The core of the "proof" is the argument of substantial equivalence to previously legally marketed predicate devices. The submission highlights that the Pikos family pulse generators were "FDA approved for use with P950037/S8, dated 08-24-99)" and that the NIPS feature is generated "entirely through the existing pulse generator and lead system."
Risk Assessment (Implied): The FDA implicitly assesses if unblocking this feature introduces new risks or changes the fundamental operating principles in a way that would necessitate a new class of controls or different regulatory pathway. The statement "There are no hardware changes... The primary functions... remain the same" directly addresses this.
Labeling Review: Ensuring the indications for use align with the predicate device and the safety profile.

Given the nature of the document, the following table and descriptions are based on the regulatory context of substantial equivalence, not a typical performance study for accuracy or diagnostic capability.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Implied Regulatory)	Reported Device Performance/Justification in Submission (Regulatory)
Safety: No new safety risks introduced by enabling NIPS feature.	"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." The NIPS feature is already approved for these pulse generators outside the US.
Effectiveness/Functional Equivalence: NIPS performs intended function (high rate pacing, EP studies) equivalently to predicate or prior use.	NIPS is provided as a feature by allowing access to existing NPS software drivers that were previously locked out. "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." This feature is generated "entirely through the existing pulse generator and lead system." The NIPS feature is approved for each pulse generator listed above outside the US.
Indications for Use: No expansion or change from predicate.	"The indications/contraindications for use of the PIKOS products are identical to those for all single chamber (AAI or VVI) pulse generators." Specific indications for use are listed on page 4, consistent with single-chamber pacemakers.
Technological Characteristics: No significant difference from predicate.	NIPS is implemented purely via software unlock of existing functionality. "There are no hardware changes" to devices or programmer. The affected pulse generators are existing models already cleared by FDA (K914109A, K923026C, K9141937).
Device Identification: Clear software version for the unlocked feature.	BIOTRONIK "will identify the software version as B-H02.0.U."

Additional Requested Information (where applicable from the text or inferred from the 510(k) context):

Sample size used for the test set and the data provenance: Not applicable in the context of this 510(k) submission. This is a regulatory clearance for a software unlock feature on existing hardware, not a performance study requiring a test set of patient data. The "acceptance" is based on the argument of substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a traditional sense for a performance study. Regulatory review team at FDA serves as the "technical experts" assessing the submission.
Adjudication method for the test set: Not applicable. No test set requiring adjudication of results.
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, nor a comparative effectiveness study involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device. The NIPS feature is an integrated function of a pacemaker controlled by a programmer with human input.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a performance study. The "truth" for this submission is regulatory (i.e., substantial equivalence to predicate devices and established safety/efficacy of the base pacemakers).
The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set. The functionality is based on pre-existing, already developed and tested software drivers within an established device.
How the ground truth for the training set was established: Not applicable.

Summary

{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
	PikosClass IIIImplantable Pacemaker Pulse Generator74 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

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.

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)

Regulation Number and Section

§ 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.