(27 days)
The TandemHeart Transseptal Cannula Set-EF 72 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 the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
The TandemHeart Transseptal Cannula Set-EF 72 consists of three main components, a 21 Fr Transseptal Cannula, a 14 Fr Obturator, and a 14/21 Fr Two-stage Dilator which are intended for the drainage of the left atrium during left ventricular bypass.
The provided text describes a 510(k) submission for a medical device, the CardiacAssist TandemHeart Transseptal Cannula Set-EF 72. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics as one might find in a full clinical trial report or a study evaluating an AI algorithm.
Therefore, the requested information elements related to AI/algorithm performance, ground truth, expert consensus, and sample sizes for testing and training sets for an AI device are not applicable to this submission. This document pertains to a medical device's physical and functional characteristics.
However, I can extract the information that is relevant and map it to the closest corresponding categories where possible.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The "acceptance criteria" here are implicitly linked to the performance of the predicate devices. The study performed aims to demonstrate that the new device's performance aligns with or is substantially equivalent to these predicates.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (TandemHeart Transseptal Cannula Set-EF 72) |
|---|---|
| Flow vs. Pressure Drop (HQ) Performance (consistent with predicate THTC-EF cannula over 6 hours) | Flow vs. Pressure Drop (HQ) testing indicated a flow performance after six-hour use that was consistent with the longer length and substantially equivalent to the predicate THTC-EF cannula. |
| Hemolysis (consistent with predicate devices) | Hemolysis testing demonstrated that the THTC-EF 72 cannula was substantially equivalent in performance to the predicate devices. |
| Radiopaque Marker Disc Mechanical Integrity (consistent with predicate devices) | Radiopaque marker disc testing demonstrated that the THTC-EF 72 cannula was substantially equivalent in performance to the predicate devices. |
| Suture Ring Performance (consistent with predicate devices) | Suture ring testing demonstrated that the THTC-EF 72 cannula was substantially equivalent in performance to the predicate devices. |
Since this is a 510(k) summary for a physical medical device and not an AI algorithm, the following points are not directly applicable or inferable from the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission. Performance data refers to bench testing rather than patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): "Ground truth" in this context would be the measured physical and mechanical properties from the bench tests, compared against the known properties of the predicate devices.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo consists of a stylized heart symbol to the left of the company name. The text "CardiacAssist, Inc." is written in a bold, sans-serif font.
K08 ayas
SEP 1 8 2008
Section VIII 510(k) Summary
Date 20 August 2008
Applicant
CardiacAssist, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 x229 Fax: 412-963-0800
Contact: Robert Bollinger Title: Director of Quality e-mail: rbollinger(@cardiacassist.com
Device
Trade/Proprietary Name: CardiacAssist TandemHeart Transseptal Cannula Set-EF 72 Common Name: Enhanced Flow Transseptal Cannula, 72 cm Classification Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing
Predicate Devices
CardiacAssist TandemHeart Transseptal Cannula Set-EF (K052570) CardiacAssist Transseptal Cannula Set (K030398) Medtronic BioMedicus Pediatric Femoral Venous Cannula (K872033)
Device Description
The TandemHeart Transseptal Cannula Set-EF 72 consists of three main components, a 21 Fr Transseptal Cannula, a 14 Fr Obturator, and a 14/21 Fr Two-stage Dilator which are intended for the drainage of the left atrium during left ventricular bypass.
Image /page/0/Figure/14 description: The image shows a medical device with several labeled parts. The device is identified as a 21 Fr TandemHeart Transseptal Cannula, along with a 14 Fr Obturator and a 14/21 Fr Dilator. Key components labeled include a Blue Protective Cap, Clamp Area, Suture Wing, Insertion Depth Markers, Suture Rings, Barbed Connector, Obturator Hub w/Luer, Flush Holes, and Hemostasis Cap.
Radiopaque Discs not Oriented to Side Holes, Print or Bend
{1}------------------------------------------------
്ത് CardiacAssist, Inc.
Intended Use
The TandemHeart Transseptal Cannula Set-EF 72 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 the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
Comparison of Technological Characteristics
The Transseptal Cannula Set-EF 72 is identical in construction to the predicate Transseptal Cannula Set-EF, with the exception that it is 10 cm longer in length. The increase in length results in a slightly higher pressure drop in the cannula. The Transseptal Cannula Set-EF 72 also contains suture rings in a separate sterile pouch, which are manufactured from the same material used to make the suture wings in the predicate Transseptal Cannula Set-EF. These rings are identical to those in the predicate CardiacAssist Transseptal Cannula set that was cleared under K030398. The Transseptal Cannula Set-EF 72 also has encapsulated Radiopaque Marker discs at the cannula tip for clear visualization under fluoroscopy. These markers are identical to those utilized in the predicate BioMedicus Pediatric Femoral Venous Cannula that was cleared per K872033.
Performance Data
A risk assessment was conducted to determine the impact of the changes and the appropriate testing to perform. Subsequently, testing of the TandemHeart Transseptal Cannula Set-EF 72 was completed to verify flow vs. pressure drop (HQ), suture ring performance, mechanical integrity of the radiopaque marker disc encapsulation, and hemolysis. The Transseptal Cannula-EF 72 HQ testing results indicated a flow performance after six hour use that was consistent with the longer length, and substantially equivalent to the predicate THTC-EF cannula. The results of hemolysis testing, radiopaque marker disc testing and suture ring testing demonstrated that the THTC-EF 72 cannula was substantially equivalent in performance to the predicate devices.
Conclusions
The CardiacAssist TandemHeart Transseptal Cannula Set-EF 72 is substantially equivalent to the predicate CardiacAssist TandemHeart Transseptal Cannula Set-EF in design characteristics, performance, materials, method of construction, and intended use. The suture rings of the CardiacAssist TandemHeart Transseptal Cannula Set-EF 72 are also substantially equivalent to the predicate CardiacAssist Transseptal Cannula Set. The Radiopaque Marker disks at the tip of the CardiacAssist TandemHeart Transseptal Cannula Set-EF 72 are substantially equivalent to those in the BioMedicus Pediatric Femoral Venous Cannula.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus.
SEP 1 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Bollinger Director of Quality Assurance CardiacAssist, Inc. 240 Alpha Dr. Pittsburgh, PA 15238
K082425 Re:
TandemHeart Transseptal Cannula Set-EF 72, Model No. 5140-6217 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: August 20, 2008 Received: August 22, 2008
Dear Mr. Bollinger:
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 - Mr. Robert Bollinger
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 sct 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on vour 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.
R. Vuchner
A Bram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
് CardiacAssist, Inc.
Section VII
Indications for Use Statement
510(k) Number: KO82A25
Device Name: CardiacAssist TandemHeart Trannseptal Cannula- EF 72
Indication for Use: The TandemHeart Transseptal Cannula Set-EF 72 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 the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Holmes
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number ko82425
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).