(14 days)
Not Found
No
The 510(k) summary describes a standard medical device (tubing sets for cardiopulmonary bypass) and does not mention any AI or ML components, algorithms, or functionalities. The testing described is focused on material properties and performance, not software or data analysis.
Yes
The device is used in extracorporeal circulation during cardiopulmonary bypass procedures, which is a therapeutic intervention to support heart and lung function during surgery.
No
The device is a tubing set used for extracorporeal circulation during cardiopulmonary bypass procedures, which is a supportive function, not a diagnostic one. It facilitates the procedure rather than identifying a disease or condition.
No
The device description clearly states it is a sterile, non-pyrogenic device consisting of tubing, connectors, oxygenators, reservoirs, filters, and other physical components used in extracorporeal circulation. This is a hardware-based 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 for extracorporeal circulation during cardiopulmonary bypass procedures. This is a therapeutic procedure performed on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device consists of tubing, connectors, and other components for assembling a circuit to support extracorporeal circulation. It does not involve analyzing biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical properties of the tubing and connectors (bond strength, burst pressure, hemolysis, spallation) and their equivalence to existing devices used in extracorporeal circulation. There are no studies related to the accuracy or reliability of diagnostic measurements.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to support a life-sustaining procedure during surgery.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWE
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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.
K833322, K771692, K013578, K041697, K881330, K800178, K023132
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
§ 870.4390 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).
0
K 053025
510 (K) Summary
| Submitter: | Maquet Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen
Germany |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Johnson
Phone: 641-472-0775
Fax: 641-472-0241
E-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 tubing
Cardiopulmonary bypass vascular catheter,
or tubing
Cardiopulmonary bypass adaptor, stopcock,
manifold, or fitting |
| Predicate Devices: | Tubing and Connectors:
Gish Biomedical, Tubing Connectors - K833322
Cobe Cardiovascular, Tubing Sets - K771692
Terumo Cardiovascular Systems, Pump Tubing -
K013578
Terumo Cardiovascular Systems, Circuit
Connectors - K041697
Tubing Sets:
Cobe Cardiovascular, Cobe Heart-Lung Perfusion
and Cardioplegia Pack - K881330
Medtronic Perfusion Systems, Intersept Blood
Tubing Packs - K800178
Maquet 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.
1
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.
2
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.
3
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
4
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