(14 days)
The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, fifters, and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support up to six hours.
Tubing with a 3/32 inch wall thickness may also be used in a roller type displacement blood pump to propel the blood/fluid through the circuit.
The Maquet tubing is made of polyvinyl chloride (PVC) and ranges in size from 1/8" diameter to 1/2" diameter.
The following generic types of barbed connectors will be used: straight with or without luer locks, reducer with or without luer port, Y with or without luer port, male or female luer locks. Connectors may range in size from 1/8 to 1/2 inch.
The Maquet Cardiopulmonary AG Jostra HLM Tubing Set is a sterile, non-pyrogenic device intended for single use in extracorporeal circulation during cardiopulmonary bypass procedures lasting up to six hours. This summary outlines the acceptance criteria and the study that demonstrates the device meets these criteria.
The acceptance criteria for the Jostra HLM Tubing Set revolved around demonstrating that its components (tubing and connectors) are safe and effective for their intended use and are substantially equivalent to currently marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tubing and connectors met biocompatibility standards. The submission states, "The tubing and connectors have undergone biocompatibility...testing to demonstrate safety...for their intended use." This implies that the materials and their interaction with blood and tissues are deemed safe and non-toxic for the intended duration of use (up to six hours). |
| Performance | The device demonstrated performance equivalence to predicate devices. The submission specifies, "The tubing and connectors have undergone...performance testing to demonstrate...equivalence for their intended use." Specific tests performed include: 1. Bond strength: Performed on the tubing and connectors. 2. Burst pressure: Performed on the tubing and connectors. 3. Effects upon cellular components (hemolysis): Performed on the tubing and connectors, indicating a measure of blood compatibility. 4. Spallation: Performed on the tubing and connectors, assessing resistance to shedding particles. The non-clinical tests' overall conclusion was that the materials "are safe and effective for their intended use." Additionally, the data supported that "Maquet tubing and connectors are substantially equivalent to the tubing and connectors that currently hold market clearance." This also extended to the complete "Jostra HLM Tubing Sets," which were deemed "substantially equivalent to the Custom Tubing Packs that currently hold market clearance." |
| Intended Use | The device is suitable for extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less. The "Indications for Use" explicitly state: "The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less." |
| Sterility | The device is provided sterile. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only." |
| Non-pyrogenicity | The device is non-pyrogenic. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only." |
| Single Use Only | The device is designed for single use and not to be re-sterilized. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample size for each performance or biocompatibility test performed (e.g., number of tubing segments for burst pressure, number of samples for hemolysis). The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based and conducted in a controlled environment, likely by the manufacturer or a contract testing lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of device and study described. The ground truth for this device is established through objective, standardized engineering and biological tests (e.g., measuring bond strength, burst pressure, hemolysis rates) against predefined criteria or comparison to predicate devices, rather than expert interpretation of data.
4. Adjudication Method
Not applicable. The "adjudication method" usually refers to a process of resolving discrepancies in expert interpretations, which is not relevant for objective laboratory and physical performance tests of a device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is not an AI-powered diagnostic tool or a device that involves human interpretation of output. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical device (tubing set) and does not involve an algorithm or AI.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily objective, quantifiable laboratory measurements and performance metrics according to standardized protocols. This includes:
- Engineering specifications (e.g., bond strength and burst pressure measurements).
- Biological responses (e.g., hemolysis and spallation tests).
- Comparison to established performance characteristics of predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K 053025
510 (K) Summary
| Submitter: | Maquet Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany |
|---|---|
| Contact Person: | Kathleen JohnsonPhone: 641-472-0775Fax: 641-472-0241E-mail: kathleen@mdai.net |
| Date Prepared: | August 27, 2005 |
| Device Trade Name: | Jostra HLM Tubing Set |
| Common/Usual Name: | Custom tubing pack |
| Classification Names: | Cardiopulmonary bypass pump tubingCardiopulmonary bypass vascular catheter,or tubingCardiopulmonary bypass adaptor, stopcock,manifold, or fitting |
| Predicate Devices: | Tubing and Connectors:Gish Biomedical, Tubing Connectors - K833322Cobe Cardiovascular, Tubing Sets - K771692Terumo Cardiovascular Systems, Pump Tubing -K013578Terumo Cardiovascular Systems, CircuitConnectors - K041697Tubing Sets:Cobe Cardiovascular, Cobe Heart-Lung Perfusionand Cardioplegia Pack - K881330Medtronic Perfusion Systems, Intersept BloodTubing Packs - K800178Maquet Cardiopulmonary, Jostra MECC Set -K023132 |
Device Description:
The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, fifters, and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support up to six hours.
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Tubing with a 3/32 inch wall thickness may also be used in a roller type displacement blood pump to propel the blood/fluid through the circuit.
The Maquet tubing is made of polyvinyl chloride (PVC) and ranges in size from 1/8" diameter to 1/2" diameter.
The following generic types of barbed connectors will be used: straight with or without luer locks, reducer with or without luer port, Y with or without luer port, male or female luer locks. Connectors may range in size from 1/8 to 1/2 inch.
Indications for Use:
The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
Statement of Technical Comparison
The Jostra HLM Tubing Set has the same intended use, design and materials, principle of operation and performance as product that is commercially available.
Non-clinical Testing
The tubing and connectors have undergone biocompatibility and performance testing to demonstrate safety and equivalence for their intended use in the Jostra HLM Tubing Set. All other components in the custom tubing pack are legally marketed devices used in accordance with their intended use.
The following tests have been performed on the tubing and connectors:
-
- Bond strength
-
- Burst pressure
-
- Effects upon cellular components (hemolysis)
-
- Spallation
The non-clinical tests have demonstrated that the tubing and connectors used to produce the Jostra HLM Tubing Sets are safe and effective for their intended use.
These data support that Maquet tubing and connectors are substantially equivalent to the tubing and connectors that currently hold market clearance.
The Jostra HLM Tubing Sets are substantially equivalent to the Custom Tubing Packs that currently hold market clearance.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
NOV 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maquet Cardiopulmonary AG c/o Mr. Daniel W. Lehtonen Staff Engineer, Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BoxBorough, MA 01719
Re: K053025
Trade Name: Jostra HLM Tubing Set Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWE Dated: October 26, 2005 Received: October 27, 2005
Dear Mr. Lehtonen:
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.
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Page 2 - Mr. Daniel W. Lehtonen
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 (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 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/industry/support/index.html.
Sincerely yours,
Dina R. Vihines
\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K 6 5 30 2 5
Device Name: _____ Jostra HLM Tubing Set
Indications for Use:
13:14 :
The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
e R. A.chner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko كلح 330 كليك
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).