(23 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on mechanical compression.
Yes
The device is described as an "adjunct to manual CPR" and is used to compress the chest of adult patients in cases of clinical death, indicating a therapeutic purpose to aid in resuscitation.
No
The device is described as an automated chest compression system, an "adjunct to manual CPR," used for resuscitation by compressing the chest. It does not collect or analyze any physiological data to diagnose a condition.
No
The device description explicitly states it is a "battery powered device" with a "single use chest compression assembly," a "reusable platform," a "drive mechanism," a "control system," and a "power system (rechargeable battery)," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide automated chest compressions as an adjunct to manual CPR on adult patients experiencing clinical death. This is a therapeutic intervention performed on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is described as a system that compresses the chest. This is a mechanical action, not a process of analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the AutoPulse Resuscitation System Model 100 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Product codes
DRM
Device Description
AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest (for compression)
Indicated Patient Age Range
adult patients only
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)
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device. Testing of the device modifications demonstrates the device meets and improves upon the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063602 AutoPulse® Resuscitation System Model 100
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
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510(k) Summary
MAR 1 9 2008
| "Concernal proposes | General Information |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Classification | Class III |
|---|---|
| Trade Name | AutoPulse® Resuscitation System Model 100 |
| Common Name | Automatic Mechanical Chest Compressor |
| Classification Name | External Cardiac Compressor 870.5200 |
| Submitter | ZOLL Circulation, Inc. |
| 249 Humboldt Court | |
| Sunnyvale, CA 94089 | |
| Phone: 408-541-2140 | |
| Fax: 408-514-1030 | |
| Contact | Mark Perkins |
| Director, Quality Assurance and Regulatory Affairs | |
| Date Prepared | September 5, 2007 |
Intended Use
The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Predicate Devices
K063602 AutoPulse® Resuscitation System Model 100
Device Description
AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).
1
Image /page/1/Picture/1 description: The image shows the words "ZOLL Circulation" in a bold, sans-serif font. The word "ZOLL" is in black on a white background, while the word "Circulation" is in white on a black background. The words are side by side, with "ZOLL" on the left and "Circulation" on the right.
Materials
All materials used in the manufacture of the AutoPulse Resuscitation System Model 100 are suitable for this use and have been used in numerous previously cleared products.
Testing:
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device. Testing of the device modifications demonstrates the device meets and improves upon the predicate device.
Summary of Substantially Equivalence:
The AutoPulse Resuscitation System Model 100 is equivalent to the predicate device. The indications for use, basic overall function, and materials used have been determined to be substantially equivalent.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three 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
MAR 1 9 2008
Zoll Circulation, Inc. c/o Mr. Mark Perkins Director of Quality Assurance and Regulatory Affairs 249 Humboldt Court Sunnyvale, CA 94089
K072527 Re:
AutoPulse® Resuscitation System Model 100 Regulation Number: 870.5200 Regulation Name: Compressor, Cardiac External Regulatory Class: Class III (three) Product Code: DRM Dated: February 19, 2008 Received: February 22, 2008
Dear Mr. Perkins:
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.
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Page 2 -- Mr. Mark Perkins
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 yours,
Q.S.Kl
CR 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): This Application | K072572 |
|---|---|
| Device Name: | AutoPulse® Resuscitation System Model 100 |
| Indications For Use: | The AutoPulse Resuscitation System Model 100 is |
| intended to be used as an adjunct to manual CPR, on adult | |
| patients only, in cases of clinical death as defined by lack | |
| of spontaneous breathing and pulse. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q.S.M.
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number________________________________________________________________________________________________________________________________________________________________