The BSC/CA IABC's are indicated for use in patients with the following conditions: Refractory power failure. Cardiogenic shock. Unstable refractory angina. Hemodynamically significant mechanical complications secondary to acute MI: Ventricular septal defect. Mitral valve regurgitation. Papillary muscle rupture. Cardiac support for high risk general surgical and coronary angiography/angioplasty patients. Septic shock. The intended use of the 40 cc SUMO remains identical to that of the currently marketed IABC's. All of the devices are intended to provide temporary circulatory support of the left ventricle through controlled mechanical displacement of a volume of blood in the aorta. The mechanical action of the IAB catheter therapy lowers the cardiac workload by two means : 1. Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO,). 2. Diastolic augmentation which provides an increase in the mean aortic pressure and leads to an improvement in systemic and coronary arterial perfusion. Balloon pump therapy is achieved by inserting an intra-aortic balloon catheter into the descending thoracic aorta via the common femoral artery. Balloon inflation is timed to occur during diastole, beginning with the aortic valve closure. The balloon remains inflated until the onset of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.

Device Description

The proposed 40 cc SUMO consists of a polyurethane blend symmetrical balloon at the distal end of a polyurethane-covered nylon shaft. The balloon is coated with a thin layer of silicone fluid. A Nitinol central lumen runs throughout the length of the catheter and terminates at the distal tip. This central lumen may be used to pass the device over a quidewire. The balloon is supplied prewrapped for insertion.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the 40 cc SUMO device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
1. Sheathed Insertion Test	Substantially equivalent to predicate 40 cc NICATH™	Force required for 40 cc SUMO: 41.7 oz. Force required for predicate 40 cc NICATH™: 40.7 oz.
2. Sheathless Insertion Test	Substantially equivalent to predicate BSC/CA devices, Datascope 9.5 F Percor-Stat, and Kontron/Arrow IAB (all well below 0.118 inch dilator size)	Tightest restriction the 40 cc SUMO can pass through 100% of the time: 0.100 inch. Predicate BSC/CA devices: 0.095 inch. 40 cc Datascope 9.5 F Percor-Stat: 0.100 inch. 40 cc 9 F Kontron/Arrow IAB: > 0.105 inch.
3. Maximum Pumping Rate Limit Test	Substantially equivalent to predicate 40 cc NICATH™ and Model 940	Maximum pumping rate limit (≥ 90% nominal volume inflate/deflate) for 40 cc SUMO: 170 bpm. Predicate 40 cc NICATH™: 164 bpm. Model 940: 140 bpm.
4. Reliability/Integrity Test	Able to cycle as reliably as predicate 40 cc NICATH™ (minimum 3.6 million cycles); post-reliability maximum pumping rate limit and inflate/deflate times comparable to pre-reliability; no changes in dimensions or surface wear; pass leak test.	40 cc SUMO test samples cycled for a minimum of 3.6 million cycles as reliably as the predicate 40 cc NICATH™. Post-reliability maximum pumping rate limit for 40 cc SUMO: 166 bpm (compared to 170 bpm pre-reliability). Inflate and deflate times were comparable pre- and post-reliability. No changes in dimensions or signs of surface wear were noted. One sample was damaged during removal and leaked; all other test samples passed the leak test.
5. Trackability Test	Able to track guidewire into place without incidence (no kinks, problems inserting/removing)	All 40 cc SUMO and predicate devices were able to track their guidewire into place without incidence. No catheter kinks, no guidewire kinks, and no problems encountered inserting or removing catheters through their introducer.
6. Aneurization and Burst Test	Aneurization and burst pressures substantially equivalent to predicate devices.	40 cc SUMO mean aneurization pressure: 8.0 psi. Predicate 40 cc Sensation™ mean aneurization pressure: 8.3 psi. 40 cc SUMO burst pressure: 6.3 psi. Predicate 40 cc NICATH™ mean burst pressure: 6.1 psi.
7. Transmembrane Pressure and Volume Measurement	Volume at transmembrane pressure of 50 mmHg: 40 cc +/-5%. Transmembrane pressure at 40 cc displacement: < 50 mmHg.	Volume of 40 cc SUMO at 50 mmHg transmembrane pressure: 41.7 cc (meets 40 cc +/-5%). Average transmembrane pressure for 40 cc SUMO at 40 cc displacement: 27 mmHg (meets < 50 mmHg).

Study Details

This submission relies on nonclinical (bench/laboratory) testing to demonstrate substantial equivalence, rather than clinical studies. Therefore, many of the typical clinical study parameters (like human reader performance, ground truth establishment on patient data, training set sizes from patient data) are not applicable.

Sample sizes used for the test set and the data provenance:
- Test set samples: The exact number of individual devices tested for each nonclinical test is not explicitly stated in all cases. However, the text refers to "test samples" for the Reliability/Integrity Test and Trackability Test, implying multiple units were tested. For example, "The 40 cc SUMO test samples were all able to cycle..." and "40 cc SUMO test samples were inserted..." For the other tests, results are presented as single figures (e.g., "the 40 cc SUMO at 41.7 oz," "the 40 cc SUMO maximum pumping rate limit was 170 bpm," "mean aneurization pressure of 8.0 psi"), or comparisons to predicate devices, which typically represent averages or representative results from sample sets.
- Data provenance: The data is retrospective in the sense that it refers to testing performed on the device and its predicates prior to the submission date. The "country of origin of the data" is not explicitly stated but would be assumed to be conducted by Boston Scientific Corporation/Cardiac Assist, Inc. in the US.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a nonclinical engineering and performance study, not a study involving human interpretation of medical images or patient data. Ground truth was established through engineering measurements and comparisons to predetermined specifications or predicate device performance.
Adjudication method for the test set: Not applicable. As this was a nonclinical study, there was no adjudication of expert opinions. Performance was measured objectively.
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: Not applicable. This was not a study involving AI or human readers of medical cases.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical intra-aortic balloon catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests was derived from objective engineering measurements and established performance characteristics of the device and its predicate devices. For example, comparing measured insertion force, maximum pumping rate, burst pressure, and volume displacement to predefined specifications or to the established performance of existing legally marketed devices.
The sample size for the training set: Not applicable. This was a physical device, and the evaluation was based on nonclinical performance testing, not on data used to train an AI algorithm.
How the ground truth for the training set was established: Not applicable, as there was no training set in the context of AI.

Summary

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K911613

510(k) SUMMA

Pursuant to Section 513(i)(3)(A) of the Federal Food, Drug and Cosmetic Act, Boston Scientific Corporation/Cardiac Assist (BSC/CA) is required to submit within 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." BSC/CA chooses to submit a summary of information regarding safety and effectiveness.

GENERAL INFORMATION A.

Submitter's Name: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Leo Basta Contact Person: Director, Regulatory Affairs and Clinical Research

Date of Preparation: 05 May 1997

B. DEVICE INFORMATION

Device Generic Name: Intra-Aortic Balloon Catheter

Device Trade Name: 40 cc SUMO

Classification Name: Percutaneous Intra-Aortic Balloon Catheter

். PREDICATE DEVICE INFORMATION

The following devices are referenced in this premarket notification as predicate devices for the 40 cc SUMO, subject of this submission:

K963187: Modified Labeling of BSC/CA IAB's.

K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001. Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000.

K952221: 30 and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000.

K943919: 40 cc Sensation™ for use on Datascope System 97 and St. Jude/Aries 700.

K940298: Model 940 for use on BSC/CA 3001. Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700.

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FDA has concurred with the substantial equivalence of the above referenced premarket notifications. All of these devices are currently legally marketed.

D. PROPOSED DEVICE INFORMATION

This premarket notification proposes the following changes to the current legally marketed 40 cc NICATH™:

The balloon bladder inflation diameter change from 15 mm to 17 mm and length change from 27.5 cm to 22.0 cm. The diameter and length of the proposed balloon is the same as the predicate 40 cc Sensation™

E. DEVICE DESCRIPTION

ட் INDICATIONS FOR USE

The indications for use for the 40 cc SUMO is identical to that of the currently marketed predicate devices. The indications are as follows:

· Refractory power failure.
· Cardiogenic shock.
· Unstable refractory angina.
· Impending or extending myocardial infarction (MI).
Hemodynamically significant mechanical complications secondary to acute MI:
- · Ventricular septal defect.
- · Mitral valve requraitation.
- · Papillary muscle rupture.
· Angiography/Angioplasty patients.
· Septal shock.

G. TECHNOLOGICAL CHARACTERISTICS

The 40 cc SUMO is identical to the predicate 40 cc NICATH™ except for the inflated balloon diameter and balloon length (which are the same as the predicate 40 cc Sensation™). Test data and information demonstrates that the use of the 40 cc SUMO is substantially equivalent is the performance of the predicate devices on the BSC/CA 3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000 IABP's.

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NONCLINICAL TESTS H.

1. Sheathed Insertion Test:

The force required to insert the 40 cc SUMO through it's introducer, over it's quidewire at 41.7 oz, was demonstrated to be substantially equivalent to the force required to insert the predicate 40 cc NICATH™ at 40.7 oz.

2. Sheathless Insertion Test:

The tightest restriction that the 40 cc SUMO can pass through 100% of the time is 0.100 inch which is substantially equivalent to the BSC/CA predicate devices at 0.095 inch, the 40 cc Datascope 9.5 F Percor-Stat at 0.100 inch, and the 40 cc 9 F Kontron/Arrow IAB at > 0.105 inch. All BSC/CA are well below the 0.118 inch dilator size provided for use with the sheathless introduction technique.

Maximum Pumping Rate Limit Test:

The maximum pumping rate limit, defined as the maximum pumping rate at which the balloon is able to inflate and deflate fully (greater than or equal to 90% of it's nominal volume), was measured for the 40 cc SUMO on the BSC/CA 3001 IABP. The maximum pumping rate limit was 170 bpm which is substantially equivalent to the predicate 40 cc NICATH™ at 164 bpm and Model 940 at 140 bpm.

1. Reliability/Integrity Test:
  Allen

The reliability of the 40 cc SUMO was compared to that of the predicate 40 cc NICATH™ by pumping test samples for a minimum of 3.6 million cycles. The 40 cc SUMO test samples were all able to cycle as reliably as the predicate 40 cc NICATH™

Following reliability testing, the 40 cc SUMO test samples were subjected to a maximum pumping rate limit test on the BSC/CA 3001. The maximum pumping rate limit post-reliability was 166 bpm which compares well with the pre-reliability value of 170 bpm. Inflate and deflate times were also found comparable pre-reliability versus post-reliability testing.

Dimensional inspection, visual inspection for signs of surface wear, and leak testing were performed. No changes in dimensions or signs of surface wear were noted. One test sample was damaged during removal from the maximum pumping rate limit test fixture and was found to leak during the leak testing; all other test samples passed the leak test.

1. Trackability Test:
  40 cc SUMO test samples were inserted over their quidewire, into position, and withdrawn as a set to demonstrate that the catheters can perform with their insertion accessories. All the 40 cc SUMO as well as the predicate devices were able to track their guidewire into place without incidence. There were no catheter kinks, no guidewire kinks, nor any problems encountered inserting or removing the catheters through their introducer.

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Aneurization and Burst Test:

The aneurization and burst pressures of the 40 cc SUMO were found substantially equivalent to the predicate devices. The 40 cc SUMO mean aneurization pressure of 8.0 psi which compares well with the mean aneurization pressure of 8.3 psi for the predicate 40 cc Sensation™. Results indicate that the 40 cc SUMO burst pressure of 6.3 psi compares favorably with the predicate 40 cc NICATH™ with a mean burst pressure of 6.1 psi.

Transmembrane Pressure and Volume Measurement:

The volume of the 40 cc SUMO at a transmembrane pressure of 50 mmHq was found to be 41.7 cc which meets the acceptance criteria of 40 cc +/-5%, as did the predicate devices.

At a 40 cc displacement, the 40 cc SUMO transmembrane pressure on average will be 27 mmHg which meets the acceptance criteria of < 50 mmHq, as did the predicate devices.

Additional nonclinical tests performed for previous premarket notifications and submitted as reference within this submission include abrasion testing and kink resistance testing. Biocompatability testing was performed on all materials used for the 40 cc SUMO and submitted in prior premarket notifications.

1. CLINICAL TESTS

No clinical testing was performed bv Boston Scientific Corporation/Cardiac Assist in support of this premarket notification.

J. STERILIZATION AND PACKAGING

There are no changes to the packaging and sterilization of the 40 cc SUMO as compared to the predicate devices. The catheters are placed in a plastic tray and sealed into Tyvek/Mylar pouches and sterilized using 100% ethylene oxide gas. Ethylene oxide gas residuals and bacterial endotoxin levels are monitored for compliance with maximum release limits.

K. POTENTIAL COMPLICATIONS

Potential complications associated with the use of intra-aortic balloon catheters, in general, appear in the device's Directions for Use and are reproduced below.

· Leg ischemia.
· Femoral, aortic or illiac dissection.
· Arterial injury.
· Renal artery occlusion.
· Arterial rupture.
· Arterial perforation.

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· Hypotension.
· Distal embolization.
· Death.
· Vascular thrombosis.
Short-term hemodynamic deterioration.
· Hemorrhage.
· Arteriovenous fistula formation.

CONCLUSIONS ட்

Based on the functional and performance data and information submitted in this premarket notification, Boston Scientific Corporation/Cardiac Assist believes that the 40 cc SUMO is substantially equivalent to the predicate devices, the 40 cc NICATHTM, 40 cc SensationTM and Model 940, for use on the BSC/CA 3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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Mr. Leo Basta Director, Requlatory Affairs and Clincal Research Boston Scientific Corporation One Boston Scientific Place -Natick, Massachusetts 01760-1537

Re: K971673 40cc NICATH™ Intra-Aortic Balloon Catheter Regulatory Class: III (Three) Product Code: 74 DSP Dated: May 5, 1997 Received: May 7, 1997

Dear Mr. Basta:

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, qood 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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.

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Page 2 - Mr. Leo Basta

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.qov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, 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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3535 - DSP III - Intra- aontic Balloon and Cantrol System

BOSTON SCIENTIFIC CORT

Page 1 of 2

510(k) Number (if known):

Device Name: _ 40 cc SUMO

Indications for Use:

The BSC/CA IABC's are indicated for use in patients with the following _ conditions: ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

- Refractory power failure.
x Cardiogenic shock.
x Unstable refractory angina.
★ Hemodynamically significant mechanical complications secondary to acute MI:
- - Ventricular septal defect.
- - Mitral valve regurgitation.
- ォ Papillary muscle rupture.
- Cardiac support for high risk general surgical and coronary angiography/angioplasty patients.
- Septic shock.

The intended use of the 40 cc SUMO remains identical to that of the currently marketed IABC's. All of the devices are intended to provide temporary circulatory support of the left ventricle through controlled mechanical displacement of a volume of blood in the aorta.

The mechanical action of the IAB catheter therapy lowers the cardiac workload by two means :

1. Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO,).
1. Diastolic augmentation which provides an increase in the mean aortic pressure and leads to an improvement in systemic and coronary arterial perfusion.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Otfice of Device Evaluation (ODE)

Bete R. Lemperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number k9711673

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Page 2 of 2

510(k) Number: K971673

Device Name: 40 cc SUMO

Indications for Use (continued):

Balloon pump therapy is achieved by inserting an intra-aortic balloon " catheter into the descending thoracic aorta via the common femoral artery. Balloon inflation is timed to occur during diastole, beginning with the aortic valve closure. The balloon remains inflated until the onset of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.

Regulation Number and Section

§ 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.