(106 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a cannula set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates temporary left ventricular bypass by providing a means for blood drainage and return, which is a supportive function rather than a direct therapeutic intervention to treat a disease or condition itself.
No
The device is intended for temporary left ventricular bypass by providing a means for transseptal catheterization and blood drainage/return, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (cannula, obturator, dilator) made of materials, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a surgical procedure (transseptal catheterization) to provide temporary left ventricular bypass. This is a direct intervention on the patient's body.
- Device Description: The description details physical components like cannulas, obturators, and dilators, which are instruments used for accessing and manipulating anatomical structures.
- Anatomical Site: The specified anatomical sites (left atrium, femoral vein, femoral artery) are locations within the patient's body where the device is used.
- Performance Studies: The performance studies focus on physical characteristics and functionality of the device within the body (flow, kink radius, tensile strength, leak testing, biocompatibility).
An In Vitro Diagnostic (IVD) device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.
Product codes (comma separated list FDA assigned to the subject device)
DQR
Device Description
The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire.
The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient.
The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula.
The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left atrium, femoral vein, femoral artery
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)
Testing of the Transseptal Cannula Set was completed for flow vs. pressure drop (HQ) and kink radius performance, tensile strength, leak testing and biocompatibility. The Transseptal Cannula HQ and kink radius performance after six hour use was substantially better than that of the Elecath cannula. The results of the tensile strength and leak testing indicated that the device exceeded the design requirements. The biocompatibility test results indicated that the transseptal Cannula Set successfully met the requirements of FDA's Blue Book Memorandum #G95-1 guidance and ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1300 Catheter cannula.
(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).
0
്ത് CardiacAssist, Inc.
MAY 2 3 2003
510(k) Summary
Date February 4, 2003
Applicant
CardiacAssist, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800
Contact: Tim Krauskopf Title: Sr. Vice President e-mail: tkrauskopf(@cardiacassist.com
Device
Trade/Proprietary Name: CardiacAssist-Transseptal Cannula Set Common Name: Transseptal Cannula Classification Name: Catheter Cannula
Predicate Device
Elecath Percutaneous Left Atrial Cannulation Set (K854511)
Device Description
The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire.
The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient.
1
Image /page/1/Figure/0 description: The image shows a medical device, specifically a CardiacAssist, Inc. product. The device appears to be a catheter or similar instrument, featuring a central hub with multiple ports or connections. The catheter tube is marked with numerical gradations, possibly indicating depth or measurement markers.
Figure 1. 21 Fr. Transseptal Cannula
The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula.
Image /page/1/Figure/3 description: The image shows a long, thin object that appears to be a tool or instrument. It has a cylindrical shape with a wider, more complex structure at one end, possibly a handle or connector. The object is divided into sections, with a break in the middle suggesting it might be extendable or modular. The overall impression is of a precision instrument, possibly used in engineering or a related field.
Figure 2. 13 Fr. Obturator
The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.
Figure 3. 14/21 Fr. Dilator
Intended Use
The Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.
Comparison of Technological Characteristics
The Transseptal Cannula Set contains a polyurethane Transseptal Cannula with a Suture Wing and two Suture Rings, a polyurethane Obturator, and a polyethylene Two-stage
2
്ത് CardiacAssist, Inc.
Dilator. An introducer needle, transseptal puncture kit and guidewire are to be provided by the user. The Elecath device contains a vinyl transseptal cannula and a stainless steel obturator with an extension plus an introducing catheter and needle, guidewire, and transseptal needle.
Performance Data
Testing of the Transseptal Cannula Set was completed for flow vs. pressure drop (HQ) and kink radius performance, tensile strength, leak testing and biocompatibility. The Transseptal Cannula HQ and kink radius performance after six hour use was substantially better than that of the Elecath cannula. The results of the tensile strength and leak testing indicated that the device exceeded the design requirements. The biocompatibility test results indicated that the transseptal Cannula Set successfully met the requirements of FDA's Blue Book Memorandum #G95-1 guidance and ISO 10993-1.
Conclusions
The Transseptal Cannula Set is substantially equivalent to the Elecath Percutaneous Left Atrial Cannulation Set
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2003
Cardiac Assist, Inc. c/o Mr. Tim Krauskopf Sr. Vice President 240 Alpha Drive Pirsburgh, PA 15238
Re: K030398
Cardiac Assist Transseptal Cannula Set Regulation Number: 21 CFR 870.1300 Regulation Name: Catheter cannula Regulatory Class: Class II (two) Product Code: DQR Dated: April 15, 2003 Received: April 16, 2003
Dear Mr. Krauskopf:
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.
4
Page 2 – Mr. Tim Krauskopf
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
R. De Zutter, M.D.
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
്ത് CardiacAssist, Inc.
Indications For Use
510(k) Number: KO30398
Device Name: CardiacAssist Transseptal Cannula Set
Indications For Use:
The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.
Deuth
510(k) Number K050378
Prescription Use Only