(90 days)
The proposed Dialysis Priming Sets are indicated for use to provide a means to deliver rie proposed promote from a collapsible container or vented bottle into a patient's. vascular system during dialysis procedures.
The Medisystems Dialysis Priming Sets provide a means of delivering fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures. The set consists of a flexible drip chamber with a spike for attachment to the solution container, an adjustable clamp that regulates flow, a flexible delivery tube with a two port connector. This connector will allow connection of the set to devices with compatible female luer connectors. The set will also allow connection of a separate device with compatible male luer to the set's female luer connector.
This document describes a 510(k) submission for Medisystems Dialysis Priming Sets, which are accessories for hemodialysis. The focus of the submission is on demonstrating substantive equivalence to previously cleared devices, rather than a novel device requiring a de novo clinical study for performance metrics. Therefore, many of the typical acceptance criteria and study details requested are not present in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Serve as a means to deliver fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures. | "The intended use of the Medisystems Dialysis Priming Sets is to provide a means to deliver fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures. This intended use is identical to that of the currently marketed predicate devices." |
| Technological Characteristics | Possess a spike connector, tubing, drip chamber, adjustable clamp, and a means of connection to other devices (extracorporeal tubing set or I.V. needle set). | "These technological characteristics are identical to those of the currently marketed predicate device." |
| Biocompatibility | Materials of construction must be biocompatible (especially where they differ from predicate). | "The change in some of the materials of construction have been shown to have no effect upon safety and effectiveness by the results of biocompatibility and performance testing." (Implies meeting established biocompatibility standards). |
| Performance (Physical) | Meet required physical testing standards for integrity, functionality, and durability. | "To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution... physical testing..." "The required testing is defined by written and approved procedures that conform to the product design specifications." |
| Sterility | Be sterile. | "...testing required for release includes, but is not limited to: sterility..." |
| Pyrogenicity | Be non-pyrogenic. | "...testing required for release includes, but is not limited to: pyrogenicity..." |
| Visual Examination | Pass visual inspection. | "...visual examination of both in-process and finished product." |
| Labeling | Provide appropriate and sufficient directions for use. | "The additional labeling provides alternate directions for use of the device during hemodialysis procedures for priming and rinse-back." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a specific sample size for a "test set" related to clinical performance or a comparative study against a human baseline. The testing described is primarily for manufacturing quality control and material biocompatibility.
The data provenance is for manufacturing quality control and biocompatibility testing of the device itself. It doesn't appear to involve patient data or a clinical study in the typical sense for demonstrating diagnostic or treatment efficacy. The context is a device accessory, not a diagnostic algorithm or a therapeutic drug.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this 510(k) submission. The "ground truth" here is adherence to manufacturing specifications, biocompatibility standards, and functional equivalence to predicate devices, which are typically assessed through laboratory testing and regulatory compliance, not expert consensus on clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human expert-based test set adjudication process. The testing described is laboratory and manufacturing process-based.
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
This information is not applicable. This is a submission for a physical medical device accessory (dialysis priming set), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's safety and effectiveness relies on:
- Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is that the device is "substantially equivalent" to legally marketed predicate devices in terms of intended use and technological characteristics.
- Manufacturing Specifications: "The required testing is defined by written and approved procedures that conform to the product design specifications."
- Biocompatibility Standards: The biocompatibility testing implies adherence to recognized standards.
- Sterility and Pyrogenicity Standards: These are objective laboratory tests.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. This is a physical medical device, not a machine learning algorithm.
Summary of the Study/Evidence Provided for Meeting Acceptance Criteria:
The "study" presented is the collection of evidence for a 510(k) premarket notification, aiming to demonstrate substantial equivalence to already marketed predicate devices. The primary evidence consists of:
- Comparison of Intended Use: Demonstrated identical intended use to predicate devices.
- Comparison of Technological Characteristics: Demonstrated identical technological characteristics (spike connector, tubing, drip chamber, adjustable clamp, connection means) to predicate devices.
- Verification and Validation Testing (Manufacturing & Materials):
- Biocompatibility Testing: Conducted where materials differed from the predicate, showing no effect on safety and effectiveness.
- Performance Testing: Implied comprehensive "physical testing" as part of the release specifications, ensuring the device functions as designed.
- Sterility Testing: Performed on all finished products as a release specification.
- Pyrogenicity Testing: Performed on all finished products as a release specification.
- Visual Examination: Conducted on in-process and finished products.
- Adherence to "Device Master Records": Indicating that all required testing and specifications are documented and followed according to established procedures.
The ultimate "proof" of meeting acceptance criteria for this type of submission is the FDA's determination of substantial equivalence, which was granted for K971860 on August 8, 1997. This clearance is based on the submission demonstrating that the device is as safe and effective as a legally marketed predicate device.
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Section I
510(k) Summary Required by 21 CFR §807.92
I. Submitter:
| A. Name: | McKenna & Cuneo, L.L.P.on behalf of Medisystems Corporation |
|---|---|
| B. Address: | 1900 K Street, NWWashington, DC 20006 |
C. Phone and Fax Numbers: Phone: 202-496-7500 Fax: 202-496-7756
D. Contact Person: Mr. Larry R. Pilot
II. Date of preparation of this Summary: May 2, 1997
III. Trade Name: Medisystems Dialysis Priming Sets
IV. Common Name: Dialysis Priming Sets
V. Classification Name: Hemodialysis Accessories
VI. The Marketed Device(s) to which Equivalence is Claimed: The Dialysis Priming Sets which are the subject of this submission are substantially equivalent to those described in Medisystems' 510(k) number K811837 and in Japan Medical Co., LTD. 510(k) number K895882.
VII. Product Description: The Medisystems Dialysis Priming Sets provide a means of delivering fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures. The set consists of a flexible drip chamber with a spike for attachment to the solution container, an adjustable clamp that regulates flow, a flexible delivery tube with a two port connector. This connector will allow connection of the set to devices with compatible female luer connectors. The set will also allow connection of a separate device with compatible male luer to the set's female luer connector.
VIII. Statement of Intended Use Compared to Currently Marketed Predicate Device: The intended use of the Medisystems Dialysis Priming Sets is to provide a means to deliver fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures. This intended use is identical to that of the currently marketed predicate devices.
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IX. Discussion of Technological Characteristics: The technical characteristics of the device may be divided into three elements:
-
- A spike connector that allows access to containers of solution.
-
- Tubing, drip chamber, and adjustable clamp which allow the solution to be delivered at a controlled rate.
-
- A means of connection of the set to other devices such as an extracorporeal tubing set or an I.V. needle set in order to deliver the solution into the vascular system.
These technological characteristics are identical to those of the currently marketed predicate device.
Some of the materials of construction of the proposed device differ from those of the currently marketed predicate device. This difference has no effect upon the safety and effectiveness of the device as demonstrated by the results of biocompatibility testing and performance testing of the proposed device.
X. Safety and Effectiveness: To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to: sterility, pvrogenicity, physical testing, and visual examination of both in-process and finished product.
The required testing is defined by written and approved procedures that conform to the product design specifications. This testing for the Medisystems Dialysis Priming Sets is defined in detail in the "Device Master Records."
Modifications of the currently marketed device which include additional labeling and a change in some of the materials of construction will have no effect upon the safety or effectiveness of the device. The additional labeling provides alternate directions for use of the device during hemodialysis procedures for priming and rinse-back. The change in some of the materials of construction have been shown to have no effect upon safety and effectiveness by the results of biocompatibility and performance testing.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a semi-circle around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | 8 |997
Medisystems Corporation c/o Mr. Larry R. Pilot McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108 Re: K971860
Medisystems Dialysis Priming Set Dated: May 20, 1997 ...... . .......... Received: May 20, 1997 Regulatory Class: II 21 CFR §876.5820/Product Code: 78 KOC
Dear Mr. Pilot:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in interstate 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). You may, therefore, subject to the general controls provisions of 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation attitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
h7liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section A
510(k) Number (if known): K971860
Device Name: Medisystems Dialysis Priming Sets
Indications For Use:
The proposed Dialysis Priming Sets are indicated for use to provide a means to deliver rie proposed promote from a collapsible container or vented bottle into a patient's. vascular system during dialysis procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dher Ratting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971760
Prescription Use Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.