The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

Device Description

The Occlusion Balloon Catheter consists of a catheter shaft with two independent lumens upon which an expandable balloon material is bonded. The "Guide Wire" lumen extends the length of the catheter and is used for placement of guide wires and injection of contrast for angiographic visualization. The "Balloon" lumen is used to inflate and deflate the balloon. Radiopaque markers at the location of the balloon provide fluoroscopic visualization of balloon placement. The outer diameter of the catheter shaft is coated with a hydrophilic polymer that reduces friction during manipulation in the vessel.

AI/ML Overview

The provided text describes a 510(k) summary for the SentreHeart Occlusion Balloon Catheter. However, it does not contain specific details about acceptance criteria for performance, device performance data through a study, sample sizes for testing, ground truth establishment, or human-in-the-loop studies.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
(Not specified in the document)	"Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the Occlusion Balloon Catheter is safe and effective for its intended use." (No specific performance metrics or thresholds are provided)
Biocompatibility	"Results of testing demonstrate the Occlusion Balloon Catheter is biocompatible." (No specific tests or criteria detailed)

Missing Information: The document states that functional testing and biocompatibility testing were performed but does not quantify the acceptance criteria or the results against those criteria. It relies on a general statement of "safe and effective" and "biocompatible."

2. Sample size used for the test set and the data provenance

Missing Information: The document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "functional testing" is broadly mentioned without any details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing Information: Since no specific test set or clinical study is detailed, there is no mention of experts or how ground truth would have been established. This device is a catheter, not an AI/diagnostic imaging device where expert interpretation is typically a primary ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Missing Information: No information provided.

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

Missing Information: This is not applicable to a device like an "Occlusion Balloon Catheter." MRMC studies are typically for diagnostic imaging devices where human interpretation is involved. This is a medical device for temporary occlusion, not a diagnostic tool assisted by AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing Information: This is not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing Information: For a medical device like this, "ground truth" would typically relate to the physical and mechanical properties of the device (e.g., balloon inflation pressure, burst pressure, material strength, biocompatibility results) and its ability to achieve its intended function (occlusion) in relevant models (in vitro, animal, or human studies, though clinical efficacy data isn't detailed here for the 510(k)). The document only generally refers to "functional testing."

8. The sample size for the training set

Missing Information: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Missing Information: Not applicable.

Summary of the Study Mentioned in the Document:

The document briefly mentions:

"Functional testing": Conducted to support substantial equivalence and demonstrate safety and effectiveness.
"Biocompatibility testing": Conducted for the materials used in the catheter.

Key takeaway: This 510(k) summary is for a medical device (a catheter), not a software or AI-based diagnostic tool. Therefore, many of the requested categories (like ground truth from experts, MRMC studies, training sets, algorithms) are not applicable. The document itself provides a very high-level summary of testing without specific quantitative performance data or detailed study designs. It relies on the concept of "substantial equivalence" to predicate devices rather than novel, extensive performance studies with detailed acceptance criteria for statistical clinical endpoints.

Summary

{0}------------------------------------------------

SECTION 4 - 510(K) SUMMARY

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) number: K070126

8 % .

Date Prepared: January 10, 2007 Revised February 5, 2008

Applicant Information: SentreHeart 2468 Embarcadero Way Palo Alto, CA 94303

Contact Person: Linda Guthrie, Manager Regulatory Affairs Phone Number: (650) 354-1200 (650) 354-1204 Fax Number:

Device Information:

Trade Name:	Occlusion Balloon Catheter
Classification:	Class II per 21CFR 870.1250
Classification Name:	Catheter, Percutaneous
Product Code:	DQY

Physical Description:

Intended Use:

{1}------------------------------------------------

SECTION 4 - 510(K) SUMMARY

Predicate Devices: CODA Balloon Catheter, Cook Corp (K032869) Equalizer Balloon Catheter, Boston Scientific (K021721) Sentry Balloon Catheter, Boston Scientific (993292)

Safety and Performance:

Performance

Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the Occlusion Balloon Catheter is safe and effective for its intended use.

Biocompatibility

The materials used in the Occlusion Balloon Catheter are commonly used materials in other medical devices. Results of testing demonstrate the Occlusion Balloon Catheter is biocompatible.

Summary:

Based on the intended use, product testing, and information provided in this notification, the subject device has been shown to be safe and effective for its intended use and substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of an eagle or bird-like figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem. The emblem itself is composed of three curved lines that form the shape of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB -8 908

SentreHeart Inc. c/o Ms. Linda Guthrie Manager, Regulatory Affairs 2468 Embarcadero Way Palo Alto, CA 94303

Re: K070126

Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 1, 2008 Received: February 4, 2008

Dear Ms. Guthrie:

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 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 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.

{3}------------------------------------------------

Page 2 - Ms. Linda Guthrie

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Duna R. Vochner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

and the state of the same of the same of the many of the same of the same of the same of

SECTION 3 - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ______ K070126

Device Name: Occlusion Balloon Catheter

Indications for Use: The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. h. Lunes

ivision of Cardiovascular Devices

510(k) Number_k o

Page 1 of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).