(222 days)
The triple lumen central venous Catheter is intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring and continuous or intermittent drug infusion.
- Patients requiring multiple sites for IV access.
- Patients lacking useable peripheral IV sites.
- Patients requiring central venous pressure monitoring.
- Patients requiring total parenteral nutrition.
- Patients receiving incompatible medications.
- Patients requiring multiple infusions of fluids, medications, or chemotherapy.
- . Patients subject to frequent blood sampling or receiving blood transfusions.
- Patients receiving infusions that are hypertonic, hyperosmolar or infusions that have divergent pH values.
The medical device made by Sunder Biomedical Tech, CO., LTD are triple-lumen. polyurethane catheter, 5.5 and 7.0 French in size, with three independent non-communication lumens, extension lines, luer hubs and slide clamps, placed within a vein and whose distal end is intended to be located within the vena cava (inferior of superior). Central Venous Catheter (CVC) - a tubular device with single lumen or rnulti-lumen catheter, or cannula, placed within a vein and whose distal end is intended to be located within the vena cava (inferior of superior).
The catheterization kit components are configured in a Polyester Terephthalate (PET) tray and sealed with a Tyvek lid stock, and sterilized.
The provided text describes the 510(k) premarket notification for the Sunder Central Venous Catheter Kit. It details the device, its intended use, and the performance tests conducted. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/ML powered device, which the request seems to imply by asking about specific AI/ML related study artifacts such as "MRMC comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)", "effect size", "sample sized used for the test set", "data provenance", "number of experts", "adjudication method", "type of ground truth", "training set sample size" and "how ground truth for training set was established".
The device described is a physical medical device (central venous catheter), not an AI/ML-powered diagnostic or predictive system. Therefore, the questions related to AI/ML study design are not applicable to this submission.
The document focuses on the safety and effectiveness of the physical catheter itself, comparing it to a predicate device (ARROW g* and blue Plus™ Multi-Lumen Central Venous Catheter K993691). The performance tests listed are standard for such a device.
Here's a breakdown of the information that is available, and why the other requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Performance tests" but does not provide specific acceptance criteria or quantitative results against those criteria. It summarily states: "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device."
| Test Category | Specific Test | Reported Performance |
|---|---|---|
| Functional Testing | Tensile strength and elongation test | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." |
| Anti-corrosive | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Catheter-flexural fatigue tolerance test | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Stiffness test | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Flow rate | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Catheter burst pressure test | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Catheter collapse test | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Leakage test | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Ink adhesion test | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Validation (Microbiological Test) | Sterilization Process Validation | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." |
| E.O. residual test | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." | |
| Biocompatibility (Biological Tests) | General Biocompatibility Testing (Details not specified) | "The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device." |
Information Not Present (and why it's not applicable for this type of device):
- 2. Sample size used for the test set and the data provenance: Not applicable. This document refers to physical device testing, not a data-driven model. There is no "test set" in the sense of a dataset for a software algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a catheter comes from engineering specifications and standardized testing methods, not expert consensus on data interpretation.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. 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. This is for AI/ML-powered diagnostic assistance, which is not what this device is.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, "ground truth" is defined by engineering specifications and material properties verified through physical and chemical testing.
- 8. The sample size for the training set: Not applicable. There is no "training set" for physical device manufacturing.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device and therefore does not contain the information typically required for evaluating an AI/ML-powered device. The "study that proves the device meets the acceptance criteria" is described as a series of laboratory performance, microbiological, and biocompatibility tests, which concluded that the device is "as safe as and is effective with the legally marketed predicate device."
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Section 1. -510 (k) Summary
- a) Submitter:
SUDER
Sunder Biomedical Tech. Co., Ltd
Contact person: Tony Hung
Address: 10F-1. 1-67, Wu-Chuan Rd., Taichung, Taiwan 403 R.O.C.
886-4-23755650 Phone:
Fax: 886-4-23755651
Email: tonv@sunder.com.tw
Date Summary prepared: 11/15/2002
- b) Device
| Device trade name: | Sunder Central Venous Catheter Kit |
|---|---|
| Device common name: | Central Venous Catheter (CVC) |
| Device Classification name: | Short-term catheters (less than 30 days) -PercutaneousIntravascular catheter |
c) Legally marketed device to which the device is substantially equivalent
ARROW g* and blue Plus™ Multi-Lumen Central Venous Catheter 510(k) No.: K993691
- d) Description of the device
The medical device made by Sunder Biomedical Tech, CO., LTD are triple-lumen. polyurethane catheter, 5.5 and 7.0 French in size, with three independent non-communication lumens, extension lines, luer hubs and slide clamps, placed within a vein and whose distal end is intended to be located within the vena cava (inferior of superior). Central Venous Catheter (CVC) - a tubular device with single lumen or rnulti-lumen catheter, or cannula, placed within a vein and whose distal end is intended to be located within the vena cava (inferior of superior).
The catheterization kit components are configured in a Polyester Terephthalate (PET) tray and sealed with a Tyvek lid stock, and sterilized.
-
e) Intended use of the device
The triple lumen central venous Catheter is intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring (CVP) plasma pheresis, acute hyperalimentation, continuous or int4ermittent drug infusion. -
f) Performance tests:
The following performance tests are included in the submission: -
- Functional testing
- ﺳﺮ ﺍ Tensile strength and elongation test
- Anti-corrosive -
- , ( Catheter-flexural fatigue tolerance test
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K0241007
- Stiffness test ﺮ
- ア Flow rate
- ア Catheter burst pressure test. Catheter collapse test
- تر Leakage test
- تر Ink adhesion test
-
- Validation (Microbiological test)
- ア Sterilization Process Validation
- ア E.O. residual test
-
- Biocompatibility (Biological tests)
The result of the laboratory tests demonstrate that the device is as safe as and is effective with the legally marketed predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the eagle in a circular fashion. The logo is black and white.
Public Health Service
JUL 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tony Hung President Sunder Biomedical Tech. Co. Ltd. 10F-1, 1-67, Wu-Chung Road Taichung City 403 TAIWAN R.O.C.
Re: K024007
Trade/Device Name: Sunder Central Venous Catheter Kits (SD-3L70F30J and SD-3L55F30J) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 26, 2003 Received: May 28, 2003
Dear Mr. Hung:
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. Hung
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) 594-4618. 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 yours.
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 4.
510(k) Number (if known): 서스2400 7
Device Name: SUNDER CENTRAL VENOUS CATHETER KITS (SD-3L70F30J AND SD-3L55F30J)
Indications for Use:
The triple lumen central venous Catheter is intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring and continuous or intermittent drug infusion.
- Patients requiring multiple sites for IV access.
- Patients lacking useable peripheral IV sites.
- Patients requiring central venous pressure monitoring.
- Patients requiring total parenteral nutrition.
- Patients receiving incompatible medications.
- Patients requiring multiple infusions of fluids, medications, or chemotherapy.
- . Patients subject to frequent blood sampling or receiving blood transfusions.
- Patients receiving infusions that are hypertonic, hyperosmolar or infusions that have divergent pH values.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
1
Pollara Cuceniti
510(k) Number: K024007
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).