The Propaq MD is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the Propaq MD. The Propaq MD is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq MD unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

ECG Monitoring: The Propaq MD is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia, Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The Propaq MD is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

Sp02 Monitoring: The Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc.

Respiration Monitoring: The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The Propaq MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.

Invasive Pressure Monitoring: The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

Device Description

The ZOLL Propaq MD is a multi-parameter monitor / defibrillator / external transcutaneous pacer which include the following capabilities: 3, 5 and 12-Lead ECG, pulse oximetery, non-invasive blood pressure, invasive blood pressures. CO2. temperature, data recording and printing. Propag MD has been designed for use by trained medical personnel in both out-of-hospital and in-hospital applications. The design is light weight and easy to carry for transport situations.

AI/ML Overview

This submission describes the ZOLL Propaq MD, a multi-parameter monitor/defibrillator/external transcutaneous pacer. The document focuses on demonstrating the device's substantial equivalence to existing predicate devices rather than providing a detailed study proving its performance against specific acceptance criteria. Therefore, the information requested for a study that explicitly proves device performance against acceptance criteria is largely not present in the provided text.

However, based on the information provided, we can infer some details and explicitly state what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria or quantitative performance metrics for the ZOLL Propaq MD. Instead, it states:

Feature/Function	Acceptance Criteria	Reported Device Performance
Overall Performance and Safety	Meets all functional requirements and performance specifications; complies with applicable sections of recognized industry and safety standards.	"Extensive performance testing ensures that Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards." (No specific metrics or studies are detailed in the provided text).
Substantial Equivalence to Predicate Devices	Features and functions are substantially equivalent to predicate devices.	"Propaq MD utilizes the same features and functions to the indicated predicate units" (ZOLL R Series, Welch Allyn PIC50, Welch Allyn Propaq 200 Series, Welch Allyn Spot Ultra, and Oridion Capnostream20). "The information provided in this 510k demonstrates that the Propaq MD's features and functions are substantially equivalent to that of the indicated commercially distributed units with regard to performance, safety and effectiveness." (No specific metrics or comparative study results are provided).

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the text. The document refers to "extensive performance testing" but does not detail the sample size (e.g., number of patients, number of test cases) or the provenance (country of origin, retrospective/prospective nature) of the data used for this testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the text. There is no mention of expert involvement in establishing ground truth for any test set data.

4. Adjudication Method for the Test Set:

This information is not provided in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/provided. The ZOLL Propaq MD is a multi-parameter monitor/defibrillator/pacer, not an AI-assisted diagnostic or interpretive device for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device type.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

This information is not explicitly provided in the context of an "algorithm only" performance study. The document states "extensive performance testing ensures that Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications." This implies testing of the device's integrated functionality, which may include internal algorithms, but it does not differentiate between "standalone" algorithm performance and overall device performance with human interaction.

7. The Type of Ground Truth Used:

This information is not explicitly provided in the text. Since the device monitors vital signs and performs defibrillation/pacing, the "ground truth" would implicitly be the actual physiological states (e.g., true heart rate, SpO2 levels, CO2 levels, presence of fibrillation, demand for pacing) as measured by reference standards or other validated methods during performance testing. However, the document does not specify these methods.

8. The Sample Size for the Training Set:

This information is not provided in the text. The device is a medical device, not a machine learning algorithm that typically requires a distinct "training set" in the way an AI diagnostic tool would. Development and validation would involve engineering verification and validation testing, but the concept of a "training set" as used in AI development is not directly applicable here or mentioned.

9. How the Ground Truth for the Training Set was Established:

This information is not provided in the text, as the concept of an AI "training set" and its ground truth is not discussed for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo features the word "ZOLL" in large, bold letters. Below the company name is the tagline "Advancing Resuscitation. Today." in a smaller font. There is a curved line underneath the tagline.

ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A

510(k) Summary:

Submitter's Name and Address:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655

100655

JUI 2 9 2010

Contact Person:

Paul Dias

(978) 421-9655, Ext. 9413 (978) 421-0010 FAX

Date Summary Prepared:

March 5, 2010

Unit:

ZOLL Propaq MD (Monitor Defibrillator)

Classification: Class II

Low-Energy - Defibrillators (LDD) Cardiac Monitors - including Cardiotachometer and Rate Alarms (DRT) External Transcutaneous Cardiac Non-Invasive Pacemaker (DRO) Noninvasive Blood Pressure Measurement System (DXN) Blood Pressure Computer (DSK) Carbon Dioxide Gas Analyzer (CCK) Oximeter (DQA)

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Description:

Indications for Use:

Pediatric Patient Subpopulation	Approximate Age Range
Newborn (neonate)	Birth to 1 month of age.
Infant	1 month to 2 years of age.
Child	2 to 12 years of age.
Adolescent	12 to 21 years of age.

When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use ZOLL pedi·padz® pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.

Manual Defibrillation

Use of the Propag MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

· Unconsciousness.
Absence of breathing. .
Absence of pulse. .

This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

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The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

The patient population will range from newborn (neonate) to adult.

ECG Monitoring

The Propaq MD is intended for use to monitor and/or record 3-, 5-, or 12lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.

External Transcutaneous Pacing

This product can be used for temporary external cardiac pacinq in conscious or unconscious patients as an alternative to endocardial stimulation.

The purposes of pacing include:

. Resuscitation from standstill or bradycardia of any etiology:
Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug-induced standstill (due to procainamide, quinidine, digitalis, b-blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.
. As a standby when standstill or bradycardia might be expected:
Noninvasive pacing can be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia, or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing might provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis, and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.
. Suppression of tachycardia.
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and might prevent tachycardia.
Pediatric pacing. .
Pacing can be performed on pediatric patients weighing 33 lbs. (15 kg.) or less using ZOLL pediatric hands-free therapy electrode pads.

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Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of underlying skin is recommended.

Non-Invasive Blood Pressure Monitoring

The Propaq MD is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leq. The patient population will range from newborn (neonate) to adult.

Temperature Monitoring

The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user. The patient population will range from newborn (neonate) to adult.

Sp02 Monitoring

The Propaq MD is intended for use to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. The patient population will range from newborn (neonate) to adult.

Respiration Monitoring

The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the ranqe set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The patient population will range from newborn (neonate) to adult.

CO2 Monitoring

The Propag MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The patient population will range from newborn (neonate) to adult.

Invasive Pressure Monitoring

The Propag MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult.

Substantial Equivalence:

Propag MD is substantially equivalent to the features and functions of the predicate units: ZOLL R Series (K060559), Welch Allyn PIC50 (K012766),

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Welch Allyn Propaq 200 Series (K012451), Welch Allyn Spot Ultra (K040490) and Oridion Capnostream20 (K060065) reviewed and cleared by the FDA.

Comparison of Technological Characteristics

Propaq MD utilizes the same features and functions to the indicated predicate ZOLL R Series (K060559) incorporating the Rectilinear Biphasic units: Waveform, PIC50 (K012766), Propaq 200 Series (K012451), Spot Ultra (K040490), and Capnostream20 (K060065) reviewed and cleared by the FDA.

Performance Testing:

Extensive performance testing ensures that Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards.

Conclusion

The information provided in this 510k demonstrates that the Propaq MD's features and functions are substantially equivalent to that of the indicated commercially distributed units with regard to performance, safety and effectiveness.

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Image /page/5/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 2 9 2010

Zoll Medical Corporation c/o Mr. Paul Dias Vice President, Quality Assurance and Regulatory Affairs 269 Mill Road Chelmsford, MA 01824-4105

K100654 Re:

Zoll Propag MD Regulation Number: 21 CFR 870.5300 Regulation Name: DC-defibrillator (including paddles) Regulatory Class: Class II Product Code: LDD, DRT, DRO, DXN, DSK, CCK, DQA Dated: July 13, 2010 Received: July 26, 2010

Dear Mr. Dias:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Paul Dias

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.

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 (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,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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): K100654

Device Name: ZOLL Propaq MD

. JUL 2 9 2010

Indications For Use:

Propaq MD Indications for Use

Pediatric Patient Subpopulation	Approximate Age Range
Newborn (neonate)	Birth to 1 month of age.
Infant	1 month to 2 years of age.
Child	2 to 12 years of age.
Adolescent	12 to 21 years of age.

When the pediatric patient is less than 8 years of age or weighs less than 55 lbs. (25 kg.), use ZOLL pedi•padz® pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

510(k) Number_

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Division of Cardiovascular Devices	Page 1 of 4
510(k) Number

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Manual Defibrillation

Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

. Unconsciousness.
Absence of breathing. .
. Absence of pulse.

The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

The patient population will range from newborn (neonate) to adult.

ECG Monitoring

The Propaq MD is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.

External Transcutaneous Pacing

This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.

The purposes of pacing include:

. Resuscitation from standstill or bradycardia of any etiology:
Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug-induced standstill (due to procainamide, quinidine, digitalis, b-blockers,

verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.

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. As a standby when standstill or bradycardia might be expected:
Noninvasive pacing can be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia, or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing might provide an · alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis, and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.
. Suppression of tachycardia.
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and might prevent tachycardia.
. Pediatric pacing.
Pacing can be performed on pediatric patients weighing 33 lbs. (15 kg.) or less using ZOLL pediatric hands-free therapy electrode pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of underlying skin is recommended.

Non-Invasive Blood Pressure Monitoring

The Propaq MD is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult.

Temperature Monitoring

Sp02 Monitoring

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Respiration Monitoring

The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The patient population will range from newborn (neonate) to adult.

CO2 Monitoring

The Propaq MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. The patient population will range from newborn (neonate) to adult.

Invasive Pressure Monitoring

The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply. The patient population will range from newborn (neonate) to adult.

Regulation Number and Section

§ 870.5300 DC-defibrillator (including paddles).

(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.