Used to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

Device Description

The Thomas Medical Transseptal Needle consists of a specifically curved distal portion to accommodate positioning in the cardiac anatomy when used in conjunction with a transseptal introducer. A stopcock is attached to the proximal end of the needle for air aspiration, fluid infusion, blood sampling and pressure monitoring. A pointer is included on the needle shield to show orientation of the curve.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the Transseptal Needle:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Mechanical Integrity	Hub pull test	Passed protocol requirements	All samples passed
Mechanical Integrity	Hub to Stopcock pull test	Passed protocol requirements	All samples passed
Mechanical Integrity	Wire to Handle pull test (assuming "Wire" refers to needle)	Passed protocol requirements	All samples passed
Mechanical Integrity	Needle to Hub torque force	Passed protocol requirements	All samples passed
Intended Use	Create primary puncture in interatrial septum	Functionally equivalent to predicate devices	Substantially equivalent to predicate devices

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

The provided text states, "All samples passed the protocol qualification testing requirements." It does not specify an explicit sample size for each test. It also does not provide any information about the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The text describes mechanical qualification testing, not a study involving expert assessment of a medical condition or images.

4. Adjudication Method for the Test Set

This information is not applicable as the tests conducted were mechanical qualification tests and did not involve expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. The submission is for a medical device (a needle) and not an AI or diagnostic imaging device that would typically undergo such a study. The “study” described is qualification testing to ensure the device’s mechanical integrity.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the qualification testing was the pre-defined protocol qualification testing requirements. These requirements would have defined acceptable ranges or thresholds for the mechanical properties being tested (e.g., minimum pull force, maximum torque). For the overall device, the "ground truth" for its regulatory approval was its substantial equivalence to predicate devices in terms of intended use and technological characteristics.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable for the same reasons as #8.

Summary

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510(k) Notification

III.

510(k) SUMMARY (As required by 21 C.F.R. 807.92)

A. Submitter Information

Submitter's Name: Address:

Telephone Number: Facsimile: Contact Person: Title: Date Submission Prepared:

Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355 (610) 296-3000 (610) 296-4591 Tim Stoudt Manager, Quality Engineering May 25, 2001

B. Device Information

Trade name:	Not assigned at this time.
Classification Names:	Trocar (21 C.F.R. §870. 1390)

Accessories

Predicate Devices:

Device Description:

Cook, Transseptal Needle, Daig, Transseptal Needle and C.R. Bard, USCI® Brockenbrough® Needles and

Intended Use:

The Transseptal Needle is designed to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

C. Comparison of Required Technological Characteristics

The technological characteristics of the Modified Device are the same as the Predicate Device.

D. Substantial Equivalence

The Thomas Medical Products Transseptal Needle has the same general intended use/indications for use and technological characteristics as other legally marketed devices. Therefore, based on the similarities in intended use and technological characteristics, the Thomas Medical Products Transseptal Needle is substantially equivalent to the legally marketed predicate devices.

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Qualification Testing D.

Thomas Medical Products qualification testing of the Transseptal Needle included Thomas Mouron. Froudon quality of Hub pull test, Hub to Stopcock pull test, Wire to Handle pull test and Needle to Hub torque force. All samples passed the protocol qualification testing requirements.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tim Stoudt Manager, Quality Engineering Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355

K011727 Transseptal Needle/Trocar Regulation Number: 870.1390 Regulation Name: Trocar Regulatory Class: II (two) Product Code: 74 DRC Dated: March 11, 2002 Received: March 12, 2002

Dear Mr. Stoudt:

Re:

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 for association 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.

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.

MAY 02 2002

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the logo is a stylized design featuring three abstract shapes that resemble birds in flight.

MAY 02 2002

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Page 2 - Mr. Tim Stoudt

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) 594-4586. 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,

Darlene Hill

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

Enclosure

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Page		of
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510(k) Number (if known):	K011727
Device Name:	Transseptal Needle
Indications For Use:

Used to create the primary puncture in the interatrial septum when passing an introducer
and/or catheter through the septum from the right side of the heart to the left side.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

Qeetu
Division of Cardiovascular & Respiratory Devices'
510(k) Number R011727

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1390 Trocar.

(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.