(460 days)
No
The device description explicitly states that the energy reduction for children is achieved through "purely resistive attenuation" and a "separate energy look-up table incorporated into the PAD embedded software." There is no mention of AI or ML algorithms being used for decision-making or analysis.
Yes.
The device is used to treat patients in cardiopulmonary arrest by delivering lower-energy therapy to children, which is a therapeutic intervention.
No
Explanation: The device is a Pediatric-Pak for a defibrillator, designed to deliver lower-energy therapeutic shocks to children. Its primary function is treatment, not diagnosis. The "Intended Use" section explicitly states it is "indicated for use to treat patients in cardiopulmonary arrest."
No
The device description clearly states it includes hardware components such as electrodes, lead wires, a resistive attenuator circuit board, and a molded housing. While it interacts with software in the host PAD, it is not solely software.
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 samaritan® Pediatric-Pak is a component of an automated external defibrillator (AED). Its function is to deliver an electrical shock to a patient in cardiopulmonary arrest. This is a therapeutic intervention performed directly on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it is for "treating patients in cardiopulmonary arrest." This is a treatment, not a diagnostic test.
Therefore, the samaritan® Pediatric-Pak falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation.
The samaritan Pediatric-Pak is specially designed for use with the samaritan PAD (Model SAM 300P) only. The SAM 300P, in conjunction with the Pediatric Pak, allows the samaritan® PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
Product codes
MKJ
Device Description
The samaritan® Pediatric-Pak is intended as a direct replacement for the Adult Pad-Pak but Tor use with children between the ages of 1 year and 8 years or 55 pounds (25 kilograms) in weight. The clectrodes and lead wires are identical in materials and construction to those used in the adult samaritan® Pad-Pak, cleared under K042088 for use with patient above 8 years old or 55 pounds in weight. They are use in the same way as with the adult samaritan® PAD-Pak. The energy reduction required for children is accomplished by means of purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software. The Pediatric-Pak incorporates a magnet which is sensed, on insertion, by the host PAD which automatically prompts the user "child patient" and, while the Pediatric-Pak is in position, uses the Pediatric look-up table to define the voltage and duration of the therapeutic shock commensurate with the required energy deliverable (50 Joules), taking into account the attenuation by the resistors incorporated into the Pediatric-Pak. The electrodes are sealed inside poly/foil. peelable pouches of the same materials and construction as the current adult PAD-Pak electrodes. The purely resistive attenuator circuit board is enclosed inside the Pediatric-Pak requiring a slightly lengthened version of the current PAD-Pak molded housing. A different color scheme (pink) is used to help differentiate the samaritan Pediatric-Pak from their adult counterparts. The product labeling for the samaritan® Pediatric-Pak indicates a "anterior/posterior" placement to be preferred, while allowing for the typical adult "apex/sternum" placement under some circumstances.
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
from 1 year of age to 8 years
Intended User / Care Setting
personnel who have been trained in its operation.
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)
The results of bench testing and validation against a pediatric heart rhythm database indicates that the HeartSine Technologies samaritan Pediatric-Pak is substantially equivalent in safety and effectiveness to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
EXHIBIT 2 510(k) Summary 510(k) Number K052465 Heartsine Technologies, Inc. 105 Terry Drive Newtown, PA 18940 Phone: 1-215-860-8100 Fax: 1-215-860-8192 December 6, 2006 Contact: Alan B. Hershman, RAC
1. Identification of the Device:
Proprietary-Trade Name: samaritan® Pediatric-Pak (Model SPP 351) Classification Names: Defibrillators, automatic, external 74 MKJ Common/Usual Name: Automated external defibrillator and electrodes.
2. Equivalent legally marketed device: Medtronic LIFEPAK 500, K052057
3. Indications for Use:
The samaritan Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously, They should only be used by personnel who have been trained in its operation.
The samaritan Pediatric-Pak is specially designed for use with the samaritan PAD (Model SAM 300P) only. The SAM 300P, in conjunction with the Pediatric Pak, allows the samaritan® PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
4. Description of the Devices:
The samaritan® Pediatric-Pak is intended as a direct replacement for the Adult Pad-Pak but Tor use with children between the ages of 1 year and 8 years or 55 pounds (25 kilograms) in weight. The clectrodes and lead wires are identical in materials and construction to those used in the adult samaritan® Pad-Pak, cleared under K042088 for use with patient above 8 years old or 55 pounds in weight. They are use in the same way as with the adult samaritan® PAD-Pak. The energy reduction required for children is accomplished by means of purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software. The Pediatric-Pak incorporates a magnet which is sensed, on insertion, by the host PAD which automatically prompts the user "child patient" and, while the Pediatric-Pak is in position, uses the Pediatric look-up table to define the voltage and duration of the therapeutic shock commensurate with the required energy deliverable (50 Joules), taking into account the attenuation by the resistors incorporated into the Pediatric-Pak. The electrodes are sealed inside poly/foil. peelable pouches of the same materials and construction as the current adult PAD-Pak electrodes. The purely resistive attenuator circuit board is enclosed inside the Pediatric-Pak requiring a slightly lengthened version of the current PAD-Pak molded housing. A different color scheme (pink) is used to help differentiate the samaritan Pediatric-Pak from their adult counterparts. The product labeling for the samaritan® Pediatric-Pak indicates a "anterior/posterior" placement to be preferred, while allowing for the typical adult "apex/sternum" placement under some circumstances.
1
5. Safety and Effectiveness, comparison to predicate device:
The results of bench testing and validation against a pediatric heart rhythm database indicates that the HeartSine Technologies samaritan Pediatric-Pak is substantially equivalent in safety and effectiveness to the predicate devices.
| Company | Medtronic
LIFEPAK® 500 | Heartsone
Technologies |
|---------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Model No. | Medtronic Physio-Control
Infant/Child Reduced Energy
Electrodes | Reduced Energy Pediatric Electrode
Pads For the samaritan® PAD |
| 510(k) No. | K052057 | K052465 |
| Indications | For automated defibrillation of
infants and children up to
approx. 8 years of age or 25 kg
weight. | For automated defibrillation of children
from 1 year to 8 years of age or 55 lbs (25
kg) weight. |
| Energy
Reduction | 4:1 | Fixed at 50 Joules |
| Technology | Encapsulated resistive divider
part of disposable electrode
assembly | Encapsulated resistive divider part of
disposable electrode/battery pack
assembly for the PAD model. |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing testing data and the predicate device, it is the conclusion of HeartSine Technologies, Inc that the samaritan® Pediatric-Pak in conjunction with the samaritan® PAD Model 300P are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HeartSine Technologies, Inc c/o Alan B. Hershman. RAC Quality and Regulatory Affairs 105 Terry Drive Newtown, PA, 18940
DEC 1 2 2006
Re: K052465
Trade/Device Name: Samaritan Pediatric-Pak (Model SPP351) Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: November 2, 2006 Received: November 7, 2006
Dear Mr. Hershman:
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.
3
Page 2 - Mr. Hershman
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 (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. 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 Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Bhimimon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K052465
Device Name:
The samaritan® Pediatric-Pak (Model SPP 351)
Indications for Use:
The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation.
The samaritan® Pediatric-Pak is specially designed for use only with the samaritan® PAD (Model SAM 300P). This product allows the samaritan PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blymmmon
Division Sign-Off) Division of Cardiovascular Devices KO52465 510(k) Number
Prescription Use X (21 CFR 801 Subpart D)
or
Over-The-Counter Use (21 CFR 807 Subpart C)
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