(28 days)
The HLS Cannula from MAQUET is intended for use by trained physicians only. The HLS Cannula may be utilized to cannulate suitable vessels to provide circulatory perfusion of organs and vessels by forming a connection with the extracorporeal circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.
The HLS Cannula from MAQUET is a wire-reinforced, thin-wall cannula made of polyurethane. The transparent proximal section has no reinforcement and can be clamped. Each cannula is supplied with a pre-mounted 3/8" connector and an introducer that allows a guide wire up to 0.038" to be inserted. The cannula is available with an optional percutaneous insertion kit for the Seldinger technique and optional BIOLINE or SOFTLINE Coating. The HLS Cannula comes in a range of sizes and lengths. The HLS Cannula is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The insertion kit from MAQUET comprises various components which permit access to the vessels. One insertion kit is available for the arterial cannula (PIK 100) with a length of 100 cm and one for the venous cannula (PIK 150) with a length of 150 cm. Additionally as accessories to the percutaneous insertion kit, there are two sets with further dilatators available. One set with larger dual step dilatators (18 / 20, 20 / 22, 22 / 24 Fr) for a better vessel dilation in the cases where cannulae are used bigger than 23 Fr. One set contains a smaller dilatator (8 / 10 Fr), dedicated for the insertion of the smaller cannulae like 13 Fr. As further accessories are separately guidewire sets available. These guidewire sets consist of five separately packed quidewires (lengths 100 or 150 cm) which are the identic articles as used in the Percutaneous Insertion Kit itself.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Arterial HLS Cannula 13 Fr non-coated, with BIOLINE Coating and with SOFTLINE Coating (K131666)
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a 510(k) summary for a Special 510(k), which focuses on demonstrating substantial equivalence to a previously cleared device (predicate). Therefore, it doesn't present a table of explicit, pre-defined acceptance criteria with numerical targets and the device's measured performance against those targets in the way a de novo or PMA submission might.
Instead, the "acceptance criteria" for this Special 510(k) are implied by the demonstration of substantial equivalence to the predicate devices. The study essentially aims to prove that the new device's performance is comparable or not inferior to the predicate device for relevant parameters.
Here's how we can infer the acceptance criteria and reported "performance":
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Chemically and biologically safe for its intended use. | Meets: Substantial equivalence testing performed and presented in the original HLS Cannula 510(k) (K102532) is applicable. This implies the 13 Fr cannula also meets these established biocompatibility standards. |
| Packaging: Maintains sterility and device integrity. | Meets: Substantial equivalence testing performed and presented in the original HLS Cannula 510(k) (K102532) is applicable. This implies the 13 Fr cannula's packaging meets these standards. |
| Sterility: Aseptically processed to be free from viable microorganisms. | Meets: Substantial equivalence testing performed and presented in the original HLS Cannula 510(k) (K102532) is applicable. This implies the 13 Fr cannula is also sterile. |
| Flow Rate: Provides adequate blood flow for its intended use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the flow rate is acceptable and comparable. Specific numerical acceptance criteria or performance values are not provided. |
| Kink Resistance: Resists kinking during insertion and use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the kink resistance is acceptable and comparable. It also explicitly mentions "protected from kinking - to a greater or lesser extent - by wire reinforcement" similar to the predicate. Specific numerical acceptance criteria or performance values are not provided. |
| Pressure Resistance: Withstands the pressures encountered during use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the pressure resistance is acceptable and comparable. Specific numerical acceptance criteria or performance values are not provided. |
| Integrity: Maintains structural integrity during use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the structural integrity is acceptable and comparable. Specific numerical acceptance criteria or performance values are not provided. |
| Tensile Strength: Withstands tensile forces during use. | Meets: Additional testing was performed to demonstrate substantial equivalence to the predicate devices. The conclusion states that the device has "essentially the same... performance characteristics," implying the tensile strength is acceptable and comparable. Specific numerical acceptance criteria or performance values are not provided. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each non-clinical test (Flow Rate, Kink resistance, Pressure resistance, Integrity, Tensile tests). The testing methodologies would typically involve a specific number of units for each test.
- Data Provenance: Not explicitly stated, but given the submitter is MAQUET Cardiopulmonary AG in Germany, it is highly likely the non-clinical testing was conducted in Europe (Germany or within the EU). The study is retrospective in the sense that it relies on previously conducted tests for the predicate devices and then applies additional tests specific to the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the studies are entirely non-clinical (bench testing). There is no "ground truth" derived from expert consensus on medical images or clinical outcomes in this context. The "truth" is established by direct physical measurements according to specified test standards or protocols.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are entirely non-clinical bench testing, not involving human interpretation or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study investigates human reader performance, often in image interpretation, and is not relevant for the non-clinical bench testing described for this device.
Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable as the device is a physical medical device (cannula), not software or an AI algorithm. The performance described refers to the physical attributes and function of the cannula itself, not an algorithm's output.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests is established by:
- Bench Testing Measurements: Direct physical measurements (e.g., flow rate in L/min, pressure in mmHg, force in N for tensile strength) under controlled laboratory conditions, following established test protocols and standards.
- Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is demonstrating that these measured characteristics are comparable or "essentially the same" as those demonstrated for the already cleared predicate devices.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of physical medical device bench testing or a 510(k) submission for a non-AI/software device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" or corresponding ground truth for this type of submission.
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JUL 0 5 2013
.
MAQUET Cardiopulmonary AG
Premarket Notification Special 510(k) Arterial HLS Cannula 13 Fr
510 (k) Summary [As required by 21 CFR 807.92(c)]
| Date: | June 5th 2013 |
|---|---|
| Submitter: | MAQUET Cardiopulmonary AG |
| Kehler Straße 31 | |
| 76437 Rastatt | |
| Germany | |
| Contact Person: | Sarah Betz |
| Manager Regulatory Affairs | |
| Phone: +49 7478 921-440 | |
| Fax: +49 7478 921-8667 | |
| E-mail: sarah.betz@maquet.com | |
| Device Trade Name: | Arterial HLS Cannula 13 Fr non-coated, with BIOLINE |
| Coating and with SOFTLINE Coating | |
| Common/Usual name: | HLS Cannula |
| Classification Name: | Catheter, Cannulae and Tubing, Vascular, CardiopulmonaryBypass (21 CFR 870.4210, DWF) |
{1}------------------------------------------------
MAQUET Cardiopulmonary AG Premarket Notification Special 510(k) Arterial HLS Cannula 13 Fr
K102532 HLS Cannula 15-29 Fr, MAQUET Cardiopulmonary Predicate Devices: AG, Germany K924642 Bio-Medicus One Piece Femoral Arterial Cannula 12 Fr, Medtronic, USA
Device Description:
The HLS Cannula from MAQUET is a wire-reinforced, thin-wall cannula made of polyurethane. The transparent proximal section has no reinforcement and can be clamped. Each cannula is supplied with a pre-mounted 3/8" connector and an introducer that allows a guide wire up to 0.038" to be inserted. The cannula is available with an optional percutaneous insertion kit for the Seldinger technique and optional BIOLINE or SOFTLINE Coating. The HLS Cannula comes in a range of sizes and lengths.
The HLS Cannula is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.
The insertion kit from MAQUET comprises various components which permit access to the vessels. One insertion kit is available for the arterial cannula (PIK 100) with a length of 100 cm and one for the venous cannula (PIK 150) with a length of 150 cm.
Additionally as accessories to the percutaneous insertion kit, there are two sets with further dilatators available. One set with larger dual step dilatators (18 / 20, 20 / 22, 22 / 24 Fr) for a better vessel dilation in the cases where cannulae are used bigger than 23 Fr. One set contains a smaller dilatator (8 / 10 Fr), dedicated for the insertion of the smaller cannulae like 13 Fr. As further accessories are separately guidewire sets available. These guidewire sets consist of five separately packed quidewires (lengths 100 or 150 cm) which are the identic articles as used in the Percutaneous Insertion Kit itself.
Intended Use:
The HLS Cannula from MAQUET is intended for use by trained physicians only. The HLS Cannula may be utilized to cannulate suitable vessels to provide circulatory perfusion of organs and vessels by forming a connection with the extracorporeal circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.
{2}------------------------------------------------
MAQUET Cardiopulmonary AG Premarket Notification Special 510(k) Arterial HLS Cannula 13 Fr
Technological Characteristics:
The Arterial HLS Cannula 13 Fr is substantially equivalent to the previously cleared HLS Cannula 15-29 Fr (K102532). The modification only consists of the addition of a smaller diameter. They have the same intended use, the materials used are equivalent and the design is similar. Also function and handling is comparable.
The Arterial HLS Cannula 13 Fr is comparable to the Bio-Medicus One Piece Femoral Arterial Cannula 12 Fr from Medtronic (K924642). Both are intended to be used to cannulate vessels, perfuse vessels or organs in a cardiopulmonary bypass. Standard surgical or percutaneous insertion techniques can be used. Both cannulae are made of polyurethane and are protected from kinking - to a greater or lesser extent - by wire reinforcement.
Non-clinical Tests:
Testing and evaluation on safety and effectiveness was conducted to demonstrate that the Arterial HLS Cannula 13 Fr is substantially equivalent to the existing HLS Cannulae 15-28 Fr (K102532) from MAQUET and to the Bio-Medicus One Piece Femoral Arterial Cannula 12 Fr from Medtronic (K924642).
Substantial equivalence testing performed and presented in the original HLS Cannula 510(k) is applicable for the devices included in this submission. These tests included Biocompatibility, Packaging and Sterility.
The modified devices were subjected to additional testing based on the Risk Analysis performed relative to the modifications made to the design. Additional testing included Flow Rate, Kink resistance, Pressure resistance, Integrity and Tensile tests.
Clinical Tests:
Clinical results are not required for this submission to support substantial equivalence.
Conclusion:
The Arterial HLS Cannula 13 Fr submitted in this Special 510(k) Premarket Notification has essentially the same intended use, design / technological and performance characteristics as the predicate devices. The results of all testing demonstrate that the Arterial HLS Cannula 13 Fr is substantially equivalent to the predicate.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 5, 2013
Maquet Cardiopulmonary AG c/o Sarah Betz Neue Rottenburger Str. 37 Hechingen, Germany 72379
Re: K131666
Trade/Device Name: Arterial HLS Cannula 13 Fr. non-coated, with Bioline coating and Softline coating Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: June 5, 2013 Received: June 7, 2013
Dear Ms. Betz:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Sarah Betz
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J.
Cavanaugh -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MAQUET Cardiopulmonary AG Premarket Notification Special 510(k) Arterial HLS Cannula 13 Fr
Indications for Use
KI3J666 510(k) Number (if known):
Device Name: Arterial HLS Cannula 13 Fr non-coated, with BIOLINE Coating and with SOFTLINE Coating
Indications for Use:
The HLS Cannula from MAQUET is intended for use by trained physicians only. The HLS Cannula may be utilized to cannulate suitable vessels to provide circulatory perfusion of organs and vessels by forming a connection with the extracorporeal circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.
Prescription Use __ × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kenneth J. Cavanaugh -S
§ 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).