(30 days)
The HemoSonic™ 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.
The probe jacket contains the acoustic gel into which the ultrasound crystals are placed. It consists of a plug rod, tip cap, hub, body, acoustic gel and tip.
This 510(k) submission describes a "Probe Jacket for the HemoSonic™ 200 Hemodynamic Monitor," which is an accessory to an existing hemodynamic monitor. Based on the provided information, the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance metrics against defined acceptance criteria for clinical diagnostic performance.
Therefore, many of the requested categories regarding clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness are not applicable or not explicitly detailed in this type of submission. This 510(k) is about a device component whose safety and effectiveness are established through physical and material property testing, rather than a diagnostic algorithm.
Here's the breakdown of what can be extracted from the provided text according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Tensile Strength | Tests were performed to demonstrate substantial equivalence. |
| Acoustic Properties | Tests were performed to demonstrate substantial equivalence. |
| Simulated Insertion | Tests were performed to demonstrate substantial equivalence. |
| Biocompatibility | Tests were performed to demonstrate substantial equivalence. |
Explanation: The document states, "Tests were performed to demonstrate substantial equivalence in the following areas: • tensile strength, • acoustic properties, • simulated insertion, and • biocompatibility." It doesn't list specific numerical acceptance criteria or performance values. The conclusion is that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices," implying successful meeting of internal criteria designed to show equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The "tests" mentioned are laboratory tests, not clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. The ground truth for laboratory tests like tensile strength or acoustic properties is based on established engineering and materials science standards, not expert adjudication of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for clinical diagnostic studies where expert consensus on interpretations is needed. For mechanical and material properties, standardized test methods are followed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic device (often AI-assisted) on human reader performance, typically in interpreting medical images or data. The "Probe Jacket" is a physical accessory and not a diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical accessory, not a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth used for the performance tests (tensile strength, acoustic properties, simulated insertion, biocompatibility) would be based on engineering standards, material specifications, and established biocompatibility testing protocols. It is not clinical "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device does not involve a "training set" in the context of machine learning or AI algorithms. The "training" for such devices would involve manufacturing process controls and quality assurance, not data training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As there is no training set in the AI sense, this question is not relevant to this device submission.
In summary: The K040802 submission for the "Probe Jacket for the HemoSonic™ 200 Hemodynamic Monitor" is a 510(k) for an accessory device. The evaluation of its safety and effectiveness relied on demonstrating substantial equivalence through laboratory tests of its physical and material properties, rather than clinical efficacy studies often associated with diagnostic devices or AI algorithms. Therefore, much of the requested information pertinent to clinical study design and AI validation is not applicable to this particular submission.
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APR 2 8 2004
| 510(k) Summary | |
|---|---|
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
| Contact person: | William G. McLainManager, Regulatory AffairsPhone: 610-378-0131, ext. 3323Fax: 610-478-3188Email: bill.mclain@arrowintl.com |
| Date summary prepared: | March 26, 2004 |
| Device trade name: | Probe Jacket for the HemoSonic™ 200 Hemodynamic Monitor. |
| Device common name: | Sheath, Jacket or Sheath Jacket. |
| Device classificationname: | FED; 21 CFR Part 876.1500; Sheath, for Endoscope |
| Legally marketeddevices to which thedevice is substantiallyequivalent: | The predicate device is the jacket used in Arrow International, theHemoSonic™ 200 Hemodynamic Monitor cleared under K031153. |
| Description of thedevice: | The probe jacket contains the acoustic gel into which the ultrasoundcrystals are placed. It consists of a plug rod, tip cap, hub, body,acoustic gel and tip. |
| Intended use of thedevice: | The probe jacket is an accessory to the HemoSonic™ 200Hemodynamic Monitor. |
| Technologicalcharacteristics: | The proposed device has the same technological characteristics asthe predicate device(s). |
| Performance tests: | Tests were performed to demonstrate substantial equivalence in thefollowing areas:• tensile strength,• acoustic properties,• simulated insertion, and• biocompatibility. |
| Conclusions: | The results of the laboratory tests demonstrate that the device is assafe and effective as the legally marketed predicate devices. |
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an image of a stylized bird with three wing segments and a tail.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2004
Arrow International, Inc. c/o Mr. William G. McLain Manager, Regulatory Affairs 2400 Bernville Road Reading, PA 19605
Re: K040802
HemoSonic™M 200 Hemodynamic Monitor Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: ' DPN Dated: March 26, 2004 Received: March 29, 2004
Dear Mr. McLain:
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. William G. McLain
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) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Donna R. Vicinel
A 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): ¥ 04 0 80 2
Device Name: HemoSonic™ 200 Hemodynamic Monitor
Indications For Use:
The HemoSonic™ 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.
Prescription Use _X
AND/OR
Over-The-Counter Use
. . . . . . . .
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dona R. La due
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K040802
§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).