(332 days)
Cook, UBD, Daig, C.R. Bard
Not Found
No
The device description and performance studies focus on mechanical properties and traditional medical device testing, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device is a needle used to create a puncture, not to treat a disease or condition. It is an access tool rather than a therapeutic instrument.
No
The device description indicates its use for creating a primary puncture and passing catheters, and its features relate to physical manipulation and fluid handling (air aspiration, fluid infusion, blood sampling, pressure monitoring). It does not describe any function related to identifying, monitoring, or predicting a disease or condition.
No
The device description clearly describes a physical needle with a curved distal portion, a stopcock, and a needle shield, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create a puncture in the interatrial septum during a medical procedure (passing an introducer/catheter). This is an invasive surgical/interventional device used directly on the patient's anatomy.
- Device Description: The description details a needle with specific physical characteristics for use within the heart.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, tissue, etc.) outside of the body to diagnose a condition, monitor treatment, or screen for diseases. IVDs are typically used in laboratories or point-of-care settings to analyze biological specimens.
This device falls under the category of a surgical or interventional device used for a specific procedure within the body.
N/A
Intended Use / Indications for 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.
Product codes
74 DRC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial septum, heart
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)
Qualification Testing: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cook, Transseptal Needle, Daig, Transseptal Needle, C.R. Bard, USCI® Brockenbrough® Needles
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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.
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.
1
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.
2
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
3
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
4
| Page | of | ||
|---|---|---|---|
| ------ | -- | ---- | -- |
| 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)
OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
Qeetu
Division of Cardiovascular & Respiratory Devices'
510(k) Number R011727
(Optional Format 1-2-96)