(88 days)
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Not Found
No
The summary describes a cryosurgical system for cardiac procedures, focusing on the physical probes and their function (freezing tissue). There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis capabilities.
Yes
The device is intended to cause a block of electrical conduction through tissue, which is a therapeutic intervention.
No
The provided text states that the device is "intended for use in minimally invasive cardiac surgery procedures" and that the cryoprobes "are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis." This describes a therapeutic, rather than a diagnostic, function.
No
The device description explicitly states it is a "Cryoprobe Set" and describes physical probes with varied tip shapes, indicating it is a hardware device used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in minimally invasive cardiac surgery procedures to treat cardiac arrhythmias by applying cryoprobes to tissue. This is a direct surgical intervention on the patient's body.
- Device Description: The description reinforces that the device is designed for introduction and use via a trocar or incision in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body, while this device is used to directly treat tissue within the body during surgery.
N/A
Intended Use / Indications for Use
The Heartport™ Maze System: Cryoprobe Set is intended for use in minimally invasive cardiac surgery procedures, including the surgical treatment of cardiac arrhythmias. The cryoprobes are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis. The Set includes probes of varied tip shapes to optimize access to the treatment site.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cardiac tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance: Heartport™ Maze System: Cryoprobe Set meets the applicable sections of ASTM F 882 -84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Frigitronics® CCS-200 Cardiac Cryosurgical System, Spembly Medical - Cardiac Cryounit and associated Cardiac Cryoprobes
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heartport c/o Ms. Marianne C. Drennan Regulatory Affairs Specialist 200 Chesapeake Drive Redwood City, CA 94063
Re: K970496
Trade Name: Heartport™ Maze System Cryoprobe Set Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL Dated: February 7, 1997 Received: February 10, 1997
Dear Ms. Drennan:
This letter corrects our substantially equivalent letter of May 9, 1997.
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. Marianne C. Drennan
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), 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/dsma/dsmamain.html
Sincerely yours,
elgmll.
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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APPENDIX A. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
97049 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Applicant Information:
MAY - 9 1997
| Date Prepared: | February 7, 1997 |
|---|---|
| Name: | Heartport, Inc. |
| Address: | 200 Chesapeake Drive |
| Redwood City, CA 94063 | |
| Contact Person: | Marianne C. Drennan |
| Regulatory Affairs Specialist | |
| Phone Number: | (415) 482-4405 |
| Fax Number: | (415) 482-4346 |
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Heartport™ Maze System: Cryoprobe Set |
| Common Name: | Cryosurgical unit and accessories |
| Product Code: | GEH |
Equivalent Devices:
The Heartport™ Maze System: Cryoprobe Set is substantially equivalent in intended use and/or method of operation to the following predicate devices:
- Frigitronics® CCS-200 Cardiac Cryosurgical System 1.
- ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ 2. Spembly Medical - Cardiac Cryounit and associated Cardiac Cryoprobes
Intended Use:
The Heartport™ Maze System: Cryoprobe Set is intended for use in minimally invasive cardiac surgery procedures, including the surgical treatment of cardiac arrhythmias. The cryoprobes are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis. The Set includes probes of varied tip shapes to optimize access to the treatment site.
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510(k) Summary of Safety and Effectiveness (continued)
Comparison To Predicate Devices:
The Heartport™ Maze System: Cryoprobe Set is equivalent in intended use and operational characteristics to the Frigitronics® Cryoprobes and the Spembly Medical Cardiac Cryoprobes. The Heartport™ Maze System: Cryoprobe Set is specifically designed for introduction and use via a trocar or incision in minimally invasive cardiac surgery procedures.
Non-Clinical Test Results:
Performance
Heartport™ Maze System: Cryoprobe Set meets the applicable sections of ASTM F 882 -84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments.
Biocompatibility
The materials used to fabricate the Heartport™ Maze System: Cryoprobe Set are similar to the predicate devices. All materials used in the Heartport™ Maze System: Cryoprobe Set have established biocompatibility.
Summary:
Based on the intended use, product information, performance data and biocompatibility information provided in this premarket notification, the Heartport™ Maze System: Cryoprobe Set has been shown to be substantially equivalent to currently marketed predicate devices.