(184 days)
The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.
The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump, which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.
Here's an analysis of the provided text regarding the 510(k) submission for the CardioThoracic Systems, Inc. Heart-LIFT Balloon Positioner, focusing on acceptance criteria and study details:
This 510(k) summary does not include the type of detailed acceptance criteria and study information typically found for devices that rely on performance metrics like sensitivity, specificity, accuracy, or reader studies. This is because the Heart-LIFT Balloon Positioner is a Class I device and its submission is based on substantial equivalence to a predicate device (Janke-Barron Heart Support manufactured by Baxter), rather than a detailed performance study with statistical endpoints.
Therefore, many of the requested categories (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
The "acceptance criteria" here are met by demonstrating that the new device is functionally similar and safe for its intended use compared to an already marketed equivalent.
Summary of Acceptance Criteria and Study Information from the Provided Text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Device is a surgical instrument intended to lift and position the heart during cardiac surgery. | The device performs as designed and is suitable for its intended use, aligning with the predicate device. |
| Patient Population: Similar to predicate device. | Not explicitly detailed, but implied to be cardiac surgery patients. |
| Anatomical Site: Similar to predicate device. | Not explicitly detailed, but implied to be the heart. |
| Functionality: Manually inflatable, latex-free balloon, malleable shaft, hand pump, flexible air tube, pressure release valve, pressure relief valve (to prevent over-inflation). | Bench testing and animal testing results verified that the Heart-LIFT Balloon Positioner performs as designed. |
| Safety: Device is safely used for its intended purpose. | Functional bench testing and animal testing were conducted to demonstrate this. |
| Substantial Equivalence: Device is substantially equivalent to the predicate device (Janke-Barron Heart Support by Baxter). | The submission claims substantial equivalence in intended use, patient population, and anatomical site. |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated for a statistical "test set." The studies mentioned are "functional bench testing" and "animal testing." These are likely engineering and pre-clinical tests, not necessarily human clinical trials with defined statistical sample sizes for a diagnostic or AI device. Data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this type of device, which is a surgical tool, would be its physical properties and its performance in a surgical environment (bench/animal testing), not expert interpretations of data like in an imaging study.
4. Adjudication method for the test set:
- Not applicable. This applies to expert reviews, which were not conducted for this type of device submission.
5. 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:
- No, not done. This type of study is relevant for AI/diagnostic devices where human reader performance is a key measure. The Heart-LIFT Balloon Positioner is a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This applies to AI algorithms.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established through functional bench testing (evaluating physical properties and operational stability) and animal testing (evaluating its ability to lift and position the heart in a living system). This is more akin to engineering performance standards and pre-clinical safety/efficacy observations rather than expert consensus, pathology, or outcomes data in a clinical trial sense.
8. The sample size for the training set:
- Not applicable. This is for AI algorithms, which this device is not.
9. How the ground truth for the training set was established:
- Not applicable. This is for AI algorithms, which this device is not.
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510(k) Summary CardioThoracic Systems, Inc. Heart-LIFT Balloon Positioner 510(k) Notification K982419
GENERAL INFORMATION
| Manufacturer: | CardioThoracicSystems, Inc. |
|---|---|
| 10600 North Tantau Avenue | |
| Cupertino, California | |
| (408) 342-1700 | |
| (408) 342-1717 FAX | |
| Est. Reg. No. 9027735 |
| Contact Person: | Michael J. Billig |
|---|---|
| Vice President, Regulatory, Quality, and Clinical | |
| Research |
July 08, 1998 Date Prepared:
DEVICE DESCRIPTION
| Classification: | Cardiovascular Surgical Instruments 21 CFR870.4500 (510(k) exempt) | ||||
|---|---|---|---|---|---|
| Trade Name: | CTS Heart-LIFT™ Balloon Positioner | ||||
| Generic/Common Name: | Heart Positioner; Cardiovascular Surgical Instrument |
PREDICATE DEVICES
Janke-BarronHeart Support manufactured by Baxter
INTENDED USE
The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.
PRODUCT DESCRIPTION
The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump,
Response to Questions K982419 CTS Heart-LIFT Balloon Positioner
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which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.
SUBSTANTIAL EQUIV ALENCE
The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery. The Heart-LIFT Balloon Positioner is substantially equivalent to the Baxter Janke-Barron Heart Support in regards to intended use, patient population and anatomical site. The predicate device is a Class I pre-amendment device.
Functional bench testing and animal testing has been conducted and the results of the testing verified that the Heart-LIFT Balloon Positioner performs as designed and is suitable for its intended use.
SUMMARY
As contained in this 510(k) summary, the CTS Heart-LIFT Balloon Positioner is substantially equivalent to the predicate device identified in that the Heart-LIFT Balloon Positioner has a similar intended use, patient population and anatomical site as the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1999
Mr. Michael J. Billig Vice President, Regulatory, Quality, and Clinical Research CardioThoraccic Systems, Inc. 10600 North Tantau Avenue Cupertino, CA 95014
Re: K982419 Heart-Lift Balloon Positioner Requlatory Class: I Product Code: 74 MWS Dated: October 20, 1998 Received: October 21, 1998
Dear Mr. Billig:
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to
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Page 2 - Mr. Michael J. Billig
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.
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) 594-4586. 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,
Thomas J. Callahon
Thomas J. Callaha n, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CardioThoracic Systems, Inc. CTS Heart-LIFT Balloon Positioner 510(k) Premarket Notification
STATEMENT OF INDICATIONS FOR USE
The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.
Naitlynn Starr for TJC
Division Sig Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
- For PRESCRIPTION USE ONLY
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§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.