(76 days)
The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
The CS100 Intra-Aortic Balloon Pump ( IABP) is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. The CS100 is equipped with the flexibility to aid medical staff in supporting a broad range of patients. It is also designed to work in conditions which are unique to the operating room, catheterization laboratory, critical care unit and transport. The CS100 IABP has three operation modes; auto, semi auto and manual. The auto operation mode provides simplicity and minimizes operator intervention. The semi-auto and manual operation modes provide operators with flexibility for difficult clinical cases.
The given text is a 510(k) summary for the Datascope CS100 Intra-Aortic Balloon Pump. This document describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study proving those criteria are met.
Here's a breakdown of why the requested information cannot be extracted from the provided text and what can be inferred:
Information Not Present in the Document:
- Table of Acceptance Criteria and Reported Device Performance: The document states that the device "complies with the voluntary standards identified in section six of this submission" and that "The results of all measurements demonstrated that the CS 100 Intra-Aortic Balloon Pump is as safe, as effective and performs as well as the predicate devices." However, it does not provide a table outlining specific performance acceptance criteria (e.g., timing accuracy, pressure limits, inflation/deflation rates) or quantitative reported device performance metrics against those criteria.
- Sample Size for the Test Set and Data Provenance: The document mentions "Performance testing" but does not specify the sample size of any test set used or where the data came from (e.g., country of origin, retrospective/prospective).
- Number of Experts Used to Establish Ground Truth and Qualifications: This information is not provided. The testing described focuses on "Hardware and software testing," "Environmental testing," "Safety testing," and "Performance testing," which are typically engineering and functional tests, not clinical evaluations requiring expert ground truth in the traditional sense.
- Adjudication Method: Not applicable or not described for the type of testing outlined.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is typically done for diagnostic imaging devices where human readers interpret results. The CS100 is an electromechanical pump, so an MRMC study is not relevant to its type of performance evaluation.
- Standalone (algorithm only) Performance: The device is a physical electromechanical system, not solely an algorithm. Its performance is always "standalone" in the sense that it operates as a device. However, if "standalone" refers to an AI component, the provided text doesn't suggest an AI algorithm separate from the device's operational modes. The "auto operational mode" is mentioned as an automated feature, but details about its specific algorithm and standalone performance metrics are not given.
- Type of Ground Truth Used: Given the nature of the device (an intra-aortic balloon pump), the "ground truth" would likely relate to objective physiological measurements and adherence to engineering specifications rather than clinical "ground truth" like pathology for a diagnostic device. The document does not specify.
- Sample Size for the Training Set: Not applicable in the context of traditional clinical or image-based AI training. The device has an "auto operation mode," but details about how this mode was "trained" (if it involves machine learning in the modern sense) are not provided. The phrase "Code design and code reviews" suggests traditional software development.
- How Ground Truth for the Training Set Was Established: See above.
What can be inferred/extracted from the provided text:
While a direct table describing acceptance criteria and a detailed study proving they are met is absent, here's what the document implies about the testing process:
1. Acceptance Criteria and Device Performance (Inferred/General)
- Acceptance Criteria (General): The device's performance must demonstrate that it is "as safe, as effective and performs as well as the predicate devices," specifically the Datascope System 96 IABP (K965236) and the Arrow AutoCAT Intra-Aortic Balloon Pump (K983866). This implies that its functional performance (e.g., inflation/deflation timing, pressure delivery, synchronization with ECG/arterial pressure) must be comparable to these established devices.
- Reported Device Performance (General): The conclusion states: "The results of all measurements demonstrated that the CS 100 Intra-Aortic Balloon Pump is as safe, as effective and performs as well as the predicate devices." This is a summary statement, not specific performance metrics.
2. Type of Study Done
The document describes a comprehensive product development and verification testing process rather than a single, specific clinical study with detailed performance metrics. The listed activities include:
- Requirements specification review
- Hardware and software testing
- Code design and code reviews
- Environmental testing
- Safety testing
- Performance testing
- Hardware and Software validation
- Auto Operation Mode (specific evaluation of this new feature)
Summary of Non-Applicable/Missing Information:
| Section | Information from Text (K031636) |
|---|---|
| Acceptance Criteria & Reported Performance | Acceptance Criteria: Implicitly, the device must be "as safe, as effective and performs as well as the predicate devices" (Datascope System 96 IABP and Arrow AutoCAT IABP). Reported Performance: "The results of all measurements demonstrated that the CS 100 Intra-Aortic Balloon Pump is as safe, as effective and performs as well as the predicate devices." (Specific quantitative criteria and performance values are NOT provided.) |
| Sample Size (Test Set) & Data Provenance | Not specified. "Performance testing" is mentioned, but no details on sample size or data origin (e.g., country, retrospective/prospective clinical data) are given. The testing appears to be primarily engineering/validation based. |
| Number & Qualifications of Experts (Ground Truth) | Not applicable or not specified. The testing described is functional/engineering validation rather than clinical assessment requiring expert interpretation for ground truth. |
| Adjudication Method | Not applicable. |
| Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | No. This type of study is not relevant for an electromechanical pump. |
| Standalone (Algorithm Only) Performance Study | Not a purely algorithmic device. The "auto operation mode" is a feature of the device; its standalone performance metrics (if any were specifically isolated from overall device performance) are not detailed. It implies testing was done for this mode as part of the overall "Performance testing" and "Hardware and Software validation." |
| Type of Ground Truth Used (Test Set) | Not explicitly stated, but for an electromechanical device, ground truth would typically be objective engineering specifications, validated physical and electrical measurements, and possibly animal or human physiological data from controlled environments to ensure synchrony and therapeutic effect. Not "expert consensus," "pathology," or "outcomes data" in the typical AI/diagnostic sense. |
| Sample Size (Training Set) | Not applicable. The device relies on traditional software (code design, code reviews) and hardware; there's no indication of a "training set" in the machine learning sense for its "auto operation mode." |
| How Ground Truth for Training Set Was Established | Not applicable. The "auto operation mode" is described as providing simplicity and minimizing operator intervention, likely developed through engineering design, control algorithms, and testing against desired physiological responses and synchronization with ECG/arterial pressure. If machine learning was involved (unlikely for this era/device type), no details are given for training or ground truth establishment. |
In conclusion, the 510(k) summary for the Datascope CS100 Intra-Aortic Balloon Pump affirms that extensive testing and validation were performed to demonstrate substantial equivalence to predicate devices, focusing on safety, effectiveness, and performance. However, it does not provide the specific quantitative acceptance criteria or detailed study results that you are requesting. Such details would typically be found in the actual test reports and validation documents submitted to the FDA, which are generally not part of the publicly available 510(k) summary.
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AUG 1 1 2003 510(k) Summary of Safety and Effectiveness
| Date: | May 21, 2003 |
|---|---|
| Submitter: | Patient Monitoring DivisionDatascope Corp. |
| Contact Person: | Susan E. MandyDirector, Clinical & Regulatory AffairsPatient Monitoring DivisionDatascope Corp.Telephone: (201)995-8025Fax:(201)995-8605 |
| Device trade name: CS100 Intra-Aortic Balloon Pump | |
| Common/usual name: Intra-aortic balloon and control system | |
| Classification name:21 CFR 870.3535 | Intra-aortic balloon and control system |
| Predicate Devices: | K965236 System 96 Intra-Aortic Balloon PumpK983866 Arrow AutoCAT Intra-Aortic Balloon Pump |
| Device Description: | The CS100 Intra-Aortic Balloon Pump ( IABP) is a cardiac assist device.It supports the heart's left ventricle by increasing coronary perfusion andreducing left ventricular work. The CS100 is equipped with the flexibilityto aid medical staff in supporting a broad range of patients. It is alsodesigned to work in conditions which are unique to the operating room,catheterization laboratory, critical care unit and transport. The CS100IABP has three operation modes; auto, semi auto and manual. The autooperation mode provides simplicity and minimizes operator intervention.The semi-auto and manual operation modes provide operators withflexibility for difficult clinical cases. |
| Intended Use: | The balloon pump is an electromechanical system used to inflate anddeflate intra-aortic balloons. It provides temporary support to the leftventricle via the principle of counterpulsation. The intra-aortic balloon isplaced in the descending aorta, just distal to the left subclavian artery.Once the balloon is positioned, the pump is adjusted to trigger insynchrony with the ECG or arterial pressure waveform to ensure thatinflation and deflation occur at the appropriate points during the cardiaccycle. The target populations are adult and pediatric. The balloon pump isintended for use in the health care facility setting. |
| Technology: | The CS100 Intra-Aortic Balloon Pump ( IABP) is substantially equivalentto the Datascope Corp. System 96 IABP, with the exception of the autooperational mode which is equivalent to the auto operation mode of theArrow International AutoCAT IABP, which is manufactured by BelmontInstrument Corporation. The CS100 has the same principles of operationas the S96 IABP and the Arrow International AutoCAT IABP. The CS100IABP is differentiated from the S96 IABP by its automated operationoption. The CS100 IABP also features improved ergonomics and a moreintuitive user interface than the System 96 IABP. |
| Test Summary | The CS100 Intra-Aortic Balloon Pump complies with the voluntarystandards identified in section six of this submission. Datascope'sproduct development process required that the following activities becompleted during the development of the CS100 Intra-Aortic BalloonPump.• Requirements specification review• Hardware and software testing• Code design and code reviews• Environmental testing• Safety testing• Performance testing• Hardware and Software validation• Auto Operation Mode |
| Conclusion | The results of all measurements demonstrated that the CS 100 Intra-AorticBalloon Pump is as safe, as effective and performs as well as the predicatedevices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2003 SEP
Datascope Corp. Patient Monitoring Division c/o Ms. Susan E. Mandy Director, Clinical and Regulatory Affairs 800 MacArthur Blvd. Mahwan, N.J. 07430
Re: K031636
CS100 Intra-Aortic Balloon Pump Regulation Number: 21 CFR 870.3535 Regulation Name: Balloon, Intra-Aortic and Control System Regulatory Class: Class III (three) Product Code: DSP Dated: May 23, 2003 Received: May 27, 2003
Dear Ms. Mandy:
This letter corrects our substantially equivalent letter of August 11, 2003 regarding the incorrect address.
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 (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 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 - Ms. Susan E. Mandy
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Roy D. Zutler, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATION FOR USE
The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.
N. De Gortu
n Sian-Off n of Cardiovascular ices 510(k) Numbe
Prescription Use Only
25
§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (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 March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.