(88 days)
No
The summary does not mention AI, ML, deep learning, or any related concepts. The device description and performance studies focus on the physical characteristics and in-vitro performance compared to existing devices.
Yes.
The device's intended use is to improve cardiovascular functioning in various medical conditions like refractory ventricular failure, cardiogenic shock, and unstable refractory angina, which indicates a therapeutic purpose.
No
The device is an intra-aortic balloon intended to improve cardiovascular functioning, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is an "intra-aortic balloon," which is a physical medical device placed in the body. The summary also lists numerous predicate and reference devices that are also physical medical devices (IABs, guidewires, introducer sets). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a device that is placed within the body (in the descending aorta) to directly improve cardiovascular function. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces that the device is placed internally for therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
Refractory ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
Product codes (comma separated list FDA assigned to the subject device)
74DSP. 74DYB. and 74DOX respectively.
Device Description
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
Refractory ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
descending aorta just below the subclavian artery
Indicated Patient Age Range
Not Found
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)
The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K790775, K905056, K910997B, K911000, K914802, K940178, K940231, K960166, K960713, K961358, K963865, K964987, K972113
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.
K904476, K904477, K924607, K943896, K955785, K904477, K943896, K952430, K960563, K961445, K970994, K971322
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
§ 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.
0
1 1998 MAY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR DATASCOPE 8Fr. CO-LUMEN (CL) INTRA-AORTIC BALLOON (IAB) & ACCESSORIES (Prepared in accordance with 21 CFR Part 807.92)
Pursuant to Section 513(I)(3)(A) of the Food, Drug, and Cosmetic act, Datascope Corp. is required to submit this Premarket Notification either an "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Datascope Corp. chooses to submit a summary of information respecting safety and effectiveness.
GENERAL INFORMATION A.
| Submitter: | Datascope Corp.
Cardiac Assist Division |
|-----------------|-------------------------------------------------------------------------|
| Address: | 15 Law Drive
Fairfield, NJ 07004 |
| Contact Person: | Whitney Torning
Manager, Regulatory Affairs and Product Surveillance |
B. DEVICE INFORMATION
| Generic Names: | Intra-Aortic Balloon (IAB), Catheter Introducer, Catheter guide wire |
|---|---|
| Trade Names: | Datascope 8Fr. Co-Lumen (CL) Intra-Aortic Balloon (IAB) and kit accessories (catheter introducer, catheter guide wire) |
| Classification Names: | Intra-Aortic Balloons (IABs) are classified under 21 CFR 870.3535, |
| Catheter Introducers are classified under 21 CFR 870.1340, and | |
| Catheter Guide Wires are classified under 21 CFR 870.1330. | |
| Product Codes: | 74DSP. 74DYB. and 74DOX respectively. |
1
C. PREDICATE DEVICE INFORMATION
Datascope's 8Fr. Co-Lumen 34 & 40cc IABs for Optional Sheathless Insertion are substantially equivalent to the devices as described in:
- K790775 -Datascope Type "S" IAB. 1)
- Datascope Percor STAT-DL 9.5Fr. IAB with Optional Insertion without K905056 -2) an Introducer Sheath. . . . . . . . . . . . . .
- K910997B Datascope Percor STAT Intra Aortic Balloons with Alternate Coating. 3)
- Datascope Percor STAT Co-Lumen 8.5Fr. 40cc IABs. K911000 -4)
- Datascope Percor STAT-DL 9.5Fr. 34cc IAB Sheathless Insertion. ર) K914802 -
- Datascope Percor STAT-DL 9.5Fr. 34cc & 40cc IABs with an alternate K940178 -6) inner lumen of 80/20 hard/soft Estane
- Datascope Percor STAT-DL 9.5Fr. 40cc IAB with an alternate K940231-7) membrane material; a Polyurethane/Silicone blend.
- Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional K960166 -8) Sheathless Insertion with Alternate Inner Lumen Material (Texin).
- Arrow International 8Fr. 40cc NarrowFlex™ IAB (nitinol inner lumen) K960713 -9) Arrow International 8Fr. 40cc NarrowFlex™ IAB for sheathless K961358 insertion (nitinol inner lumen)
- Arrow International 8Fr. 30cc NarrowFlex™ IAB (nitinol inner lumen) 11) K963865 -Arrow International 8Fr.30cc NarrowFlex™ IAB for sheathless K961358 insertion nitinol inner lumen)
- Percor STAT-DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless 12) K964987 -Insertion and Percor STAT-DL 10.5Fr. 40 & 50cc IABs for Sheath Insertion with Alternate Inner Lumen Material (80/20 hard/soft Estane) & Alternate Membrane Material (Polyurethane/Silicone) blend.
- Boston Scientific Corp. Sub-9 Nitinol 30cc and 40cc IAB for Sheathless 13) K972113 -Insertion (nitinol inner lumen)
All of the above referenced premarket notifications were found substantially equivalent by FDA.
2
An insertion kit containing a catheter introducer, composed of an 8 Fr. catheter introducer sheath with integrated hemovalve and dilator, a stepped vessel dilator, and a guide wire (.020") use the same materials as previously cleared 510(k)'s.
Datascope's 8Fr. Catheter Introducer and Stepped Vessel Dilator for use with the insertion of the 8Fr. IAB is substantially equivalent to the devices as described in:
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valve
-
- Datascope's 5 to 9 Fr. Stepped Vessel Dilator K904476 -3)
- Datascope's Stiff Guidewire for use with Datascope IABs K904477 -4)
- Arrow Fischell Corp.'s Super Arrow-Flex Percutaneous Sheath న) K924607 -Introducer
- Datascope's Staged Guide Wire for use with Datascope Percor STAT-() K943896 -DL IABs
- C.R. Bard's TS and Input Percutaneous Arterial/Venous Catheter 7) K955785 -Introducer Set
All of the above referenced premarket notifications were found substantially equivalent by FDA.
Datascope's .020" guidewire for use with the insertion of the 8Fr. IAB is substantially equivalent to the devices as described in:
- Datascope's Stiff Guidewire for use with Datascope IABs 1) K904477 -Datascope's Staged Guide Wire for use with Datascope Percor STAT-2) K943896 -DL IABs Flexmedic's Finesse guide wire for coronary use 3) K952430 -Scimed Sceptor TM PTCA guide wire (platinum spring coil) 4) K960563 -Terumo's Radiofocus® Glidewire® for coronary use (nickel titanium 5) K961445 coil with platinum spring coil)
3
- Lake Region's Nitinol core and platinum coil .014" . 045"guide wire for K970994 -6) extravascular use.
- Lake Region's Nitinol core and platinum coil .014" and .018" guide wire K971322 -7) for intravascular use.
All of the above referenced premarket notifications were found substantially equivalent by FDA with the exception of K971322 which is currently pending FDA's SE decision.
Datascope's Devices described above are referenced in this Premarket Notification as predicate devices for the 8 Fr. IAB insertion kit, and catheter introducer set, and guidewire pack. All other device components that make up the insertion kit are the same as previously cleared by the FDA.
DEVICE DESCRIPTION/INTENDED USE D.
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
Refractory ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
E. TECHNOLOGICAL CHARACTERISTICS
Datascope's 8Fr. Co-Lumen IABs with accessories are substantially equivalent to the predicate devices with regard to its indications for use. They differ technologically respecting material composition and dimensional specifications of the components. The difference in material composition and dimensional specifications have been demonstrated not to affect safety or efficacy of the device.
4
NON-CLINICAL TESTS F.
The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices.
CLINICAL TESTS G.
The 8Fr. Co-Lumen 34cc and 40cc Intra-Aortic Balloon Catheter with accessories are CE Marked and commercially available in Europe.
CONCLUSIONS H.
Based on the information presented in this 510(k) premarket notification, Datascope's 8Fr. Co-Lumen IABs with accessories are considered substantially equivalent to the currently marketed predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
10000 MAY
Ms. Whitney G. Törning Manager, Regulatory Affairs & Product Surveillance Datascope Corporation Cardiac Assist Division 15 Law Drive, CN 40011 Fairfield, NJ 07004
Re : K980385 Datascope 8Fr. CO-LUMEN (CL) Intra-Aortic Balloon 34cc and 40cc (IAB) & Accessories Requlatory Class: III (Three) Product Code: DSP Dated: January 28, 1998 Received: February 2, 1998
Dear Ms. Törning:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 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 regulations.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6
Page 2 - Ms. Whitney G. Törning
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) 594-4648. 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" (21 CFR 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/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. CallaWan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known): K9803 85
Device Name: Datascope's 8Fr. Co-Lumen 34 & 40cc Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories.
Indications for Use:
- Refractory ventricular failure. 1 .
- Cardiogenic shock. 2.
- Unstable refractory angina. 3.
-
- Impending infarction.
- Mechanical complications due to acute myocardial infarction, i.e., ventricular septal 5. defect, mitral regurgitation or papillary muscle rupture.
- Ischemia related intractable ventricular arrhythmias. 6.
- Cardiac support for high risk general surgical patients and coronary 7. angiography/angioplasty patients.
-
- Septic shock.
-
- Weaning from cardiopulmonary bypass.
- Intraoperative pulsatile flow generation. 10.
-
- Support for failed angioplasty and valvuloplasty.
This information can be found in Volume 1 (Section 3 - Attachment II) of our Premarket Notification under the section titled "II. Indications".
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-the-Counter Use
Bota R. Quiperle
(Optional Format 1-2-96)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 980385 510(k) Number .
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