The Balloon Catheter is a 6 F occluding catheter with a latex balloon. It is available in three lengths: 60 cm (Model 6746), 90 cm (Model 6714), and 110 cm (Model 6747). All models provide a balloon with an inflation capacity of 1 cc and accept a maximum guide wire diameter of .035 inches. The inflated balloon diameter is 10 mm.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Guidant Balloon Catheter (K021283).

1. Acceptance Criteria and Reported Device Performance

The provided text focuses on a labeling modification for an already marketed device, meaning the device's design, materials, manufacturing, etc., are unchanged. The core of the new submission is related to the expanded indication for use. Therefore, the "acceptance criteria" revolve around demonstrating the safety and effectiveness of the device for this new indication.

Given the information, the acceptance criteria are implicitly met by demonstrating that the device is "safe and effective for use in occluding the coronary sinus to obtain a venogram," and that this performance is "acceptable within the coronary vein." The comparison is primarily against a legally marketed predicate device (Arrow Balloon Wedge Pressure Catheter) and another substantially equivalent device (Cardima VUEPORT Guiding Catheter). Specific numerical performance metrics (e.g., success rates, complication rates) are not explicitly stated in the summary, which is common for 510(k) submissions where substantial equivalence is the goal rather than demonstrating superiority against a specific threshold.

Acceptance Criteria (Inferred)	Reported Device Performance
Device is safe and effective for occluding the coronary sinus to obtain a venogram (Human Clinical).	"The results demonstrated that the Balloon Catheter is safe and effective for use in occluding the coronary sinus to obtain a venogram." Additionally, "Animal GLP and human clinical data support the modified indication for use."
Device performance is acceptable within the coronary vein (Animal Study).	"The results of the in vivo animal evaluation showed that the performance of the Balloon Catheter is acceptable within the coronary vein."
Device is substantially equivalent to predicate devices for the modified indications.	"The Balloon Catheter with the modified indication is substantially equivalent to the currently marketed Arrow Balloon Wedge Pressure Catheter (pre-enactment device) with regard to indications for use..." and "The modified indication for use is also substantially equivalent to the currently marketed Cardima VUEPORT Guiding Catheter (K973298)."

2. Sample Size Used for the Test Set and Data Provenance

Human Clinical Study: While a "clinical investigation" was conducted, the sample size is not explicitly stated in the provided document.
Animal Study (In Vivo Testing): The sample size is not explicitly stated in the provided document.
Data Provenance:
- Human Clinical Study: The document states "Human Clinical Testing Data" was collected, implying a prospective human study, but country of origin is not specified.
- Animal Study: An "animal study was conducted," implying a prospective animal study. The document mentions "GLP" (Good Laboratory Practice), which indicates a controlled experimental setting, but country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given that this is a 510(k) for a medical device (catheter) and not an AI/imaging device, the concept of "ground truth" established by human experts in the context of image interpretation or diagnostic performance doesn't directly apply in the same way.

For the human clinical study, the "ground truth" would be the observed clinical outcomes and performance of the device (e.g., successful occlusion, successful venogram, absence of complications) as assessed by the clinicians performing the procedures. The number and qualifications of these clinicians are not specified in the summary.
For the animal study, the "ground truth" would be the observed physiological responses and device performance in the animal model, assessed by the researchers/veterinarians conducting the study. Their number and qualifications are also not specified.

4. Adjudication Method for the Test Set

This is not applicable in the context of this type of medical device study. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in diagnostic studies, especially those involving image interpretation where expert disagreement might occur. For a catheter-based procedure, the assessment of safety and effectiveness would be based on direct observation and measurement during the procedure and follow-up.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.
- This type of study is primarily relevant for diagnostic imaging devices or AI tools that assist human readers in interpretation. The Guidant Balloon Catheter is an interventional device.
- The study design focuses on demonstrating the device's own safety and effectiveness for a specific physiological task (occluding the coronary sinus) and its substantial equivalence to predicate devices, rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study was not done.
- This concept is also not applicable here. The device is a physical catheter used by a clinician. Its function is inherently "human-in-the-loop," as a human operator manipulates it. There is no algorithm or AI component to be evaluated in a standalone manner.

7. Type of Ground Truth Used

Clinical Outcomes/Performance Data:
- For the human clinical study, the ground truth was based on direct observation of the device's function in occluding the coronary sinus and enabling venogram creation, along with safety observations. This aligns closest with "outcomes data" or direct "performance data."
- For the animal study, the ground truth was based on the observed physiological performance of the catheter within the coronary vein, as assessed in the in vivo animal model.

8. Sample Size for the Training Set

Not Applicable / Not Provided:
- This device is a physical medical instrument, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The device's design and manufacturing are based on established engineering principles and prior iterations/knowledge rather than iterative machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: As there is no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply. The device's design and performance benchmarks would have been established through traditional engineering, pre-clinical testing, and clinical experience with similar devices.

Summary

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K021283

510(k) Summary

1. Device Name: Guidant Balloon Catheter, Models 6714, 6746, 6747
1. Devices to Which Equivalence is Claimed: Arrow Balloon Wedge Pressure . Catheter with regard to indications for use and design, materials, manufacturing process, packaging process, sterilization process, quality control procedures, and shelf life of the device (pre-enactment device); Cardima VUEPORT Guiding Catheter (K973298) with regard to indications for use.
1. Indication for Use: The catheter is intended for use in obtaining venograms by occluding the coronary sinus.
1. Device Description: The Balloon Catheter is a 6 F occluding catheter with a latex balloon. It is available in three lengths: 60 cm (Model 6746), 90 cm (Model 6714), and 110 cm (Model 6747). All models provide a balloon with an inflation capacity of 1 cc and accept a maximum guide wire diameter of .035 inches. The inflated balloon diameter is 10 mm.
Summary of Technological Characteristics: This notification concerns a labeling 5. modification to the indications for a currently marketed device. There are no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device.
1. Summary of Substantial Equivalence: This notification concerns a labeling modification to the indications for the currently marketed device. Substantial equivalence of the proposed indications to the current indications for use are supported by animal GLP and human clinical data. All other aspects of the proposed Guidant Balloon Catheter are identical to the currently marketed Arrow Balloon Wedge Pressure Catheter (pre-enactment device). The indications for use are also substantially equivalent to those of the Cardima VUEPORT Guiding Catheter (K973298).

7. Testing Data:

In Vivo Testing

An animal study was conducted to evaluate the performance of the Balloon Catheter when used as a conduit for contrast dye administration in the coronary vein. The results of the in vivo animal evaluation showed that the performance of the Balloon Catheter is acceptable within the coronary vein. These results support use for the proposed indications.

510(k) Submission for the Guidant Balloon Catheter Guidant/CRM - March, 2001

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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is black. The background is white. The text is centered in the image.

Image /page/1/Picture/1 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 a stylized symbol consisting of three curved lines that resemble a human figure.

Public Health Service

MAY - 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen S. Alsop Pr. Regulatory Affairs Associate Guidant Corporation 4100 Hamline Avenue N St. Paul. MN 55112

Re: K021282

Trade Name: LV-1 Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold fitting Regulatory Class: Class II (two) Product Code: DTL

Re: (K021283)

Trade Name: Guidant Balloon Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO

Re: K021284

Trade Name: EASYTRAK® Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY

Re: K021285

Trade Name: HI-TORQUE® Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: April 17, 2002 Received: April 18, 2002

Dear Ms. Alsop:

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 enclosures) 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include

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Human Clinical Testing Data:

The Balloon Catheter was evaluated in a clinical investigation. The function of the Balloon Catheter in this clinical investigation was to aid in obtaining a venogram by occluding the coronary sinus. The results demonstrated that the Balloon Catheter is safe and effective for use in occluding the coronary sinus to obtain a venogram.

1. Conclusion: The Balloon Catheter with the modified indication is substantially equivalent to the currently marketed Arrow Balloon Wedge Pressure Catheter (preenactment device) with regard to indications for use, design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device. Animal GLP and human clinical data support the modified indication for use. The modified indication for use is also substantially equivalent to the currently marketed Cardima VUEPORT Guiding Catheter (K973298).
  510(k) Submission for the Guidant Balloon Catheter Guidant/CRM - March, 2001

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Page 2 - Ms. Karen S. Alsop

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 such 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.

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 begin 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 21 CFR 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Reseller

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular' and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): (To be assigned by FDA)

KO 21282

Device Name: Guidant Balloon Catheter

Indications for Use:

The catheter is intended for use in obtaining venograms by occluding the coronary sinus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter (Optional Format 1-1-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021283

510(k) Submission for the Guidant Balloon Catheter Guidant/CRM - March, 2001

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Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).