(90 days)
The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
The Gambro medical lines QuickSet® are tubing sets (bloodlines) employed in the hemodialysis equipments extracorporeal circulation: they convey the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line). The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
Here's a breakdown of the acceptance criteria and study information for the Gambro QuickSet® Bloodlines, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary focuses on demonstrating substantial equivalence through non-clinical bench testing. It does not list specific numerical acceptance criteria for each test in a dedicated table, but rather states that the tests were "successful" in demonstrating safety and effectiveness.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing | Successful |
| Biocompatibility | Successful |
| Sterilization Process Validation | Successful |
| Sterility Testing | Successful |
| Flow Rate Testing | Successful |
| Validation of Needle and Needle-less System Injection Ports | Successful |
| Compatibility with Hemodialysis Machines | Successful |
| Testing for Mechanical Hemolysis | Successful |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of bloodlines tested for flow rate, number of samples for biocompatibility).
- Data Provenance: The data provenance is from non-clinical bench testing. The country of origin is not explicitly stated, but the submission is to the US FDA by Gambro Renal Products, a US-based company, suggesting the testing was likely conducted in the US or in compliance with US regulatory standards. The testing is prospective in nature, as it was conducted to support the 510(k) submission for a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is a non-clinical bench test, not a study involving human or image-based ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is a non-clinical bench test, not a study involving human readers or expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical bloodline system, not an AI-powered diagnostic or assistive tool for human readers.
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 medical component, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by engineering specifications, recognized standards, and established laboratory methods for evaluating the performance, safety, and compatibility of medical devices like bloodlines. For example:
- Biocompatibility: Complies with ISO standards for biological evaluation of medical devices.
- Sterility: Absence of microorganisms, confirmed by validated sterility tests.
- Flow Rate: Meeting predefined flow rate specifications.
- Mechanical Hemolysis: Meeting acceptable levels of red blood cell damage.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as 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 for the same reason as point 8.
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5.0 510(K) SUMMARY
| Submitter's Name | Gambro Renal Products | JAN 3 0 2007 |
|---|---|---|
| Address | 10810 West Collins AvenueLakewood, CO 80215 | |
| EstablishmentNumber | 1713683 | |
| Date of Submission | October 31, 2006 | |
| Contact Person | Thomas B. Dowell, Regulatory Affairs Project Manager | |
| Telephone NumberFax Number | (303) 231-4094(303) 542-5138 | |
| Name of the Device | Gambro QuickSet® Bloodlines | |
| Catalogue Numbers | 018430501: Gambro QuickSet® Post-pump arterial chamber018440501: Gambro QuickSet® No arterial pressure monitoring009445601: Gambro QuickSet® No arterial pressure monitoring009558601: Gambro QuickSet® Pre-pump arterial chamber009559601: Gambro QuickSet® Post-pump arterial chamber009566601: Gambro QuickSet® Pre-pump pillow with post arterialchamber009558714: Gambro QuickSet® Pre-pump arterial chamber009566714: Gambro QuickSet® Pre-pump pillow with post arterialchamber | |
| Common or UsualName | Extracorporeal blood circuit for hemodialysers | |
| Classification Name | Classification Name: Hemodialysis system and accessoriesDevice Class: IIProduct Code: FJKRegulation Number: 21 CFR 876.5820 | |
| Identification of theLegally MarketedDevice(Predicate Device) | Gambro G Series Bloodline Sets for HemodialysisCobe Hemaflo TM Blood Tubing Sets |
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510(k) SUMMARY, continued
Device Description
The Gambro medical lines QuickSet® are tubing sets (bloodlines) employed in the hemodialysis equipments extracorporeal circulation: they convey the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line). The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
Comparison Table
| PREDICATEG Series Blood Line | PREDICATEHemaflo™ Blood Tubing Set | MODIFIED DEVICEQuickSet® Bloodlines[currently distributed] | MODIFIED DEVICEQuickSet® Bloodlines[new models] | |
|---|---|---|---|---|
| Indication for Use | The Gambro G series blood lines are intended for use during hemodialysis in conjunction with an artificial kidney (hemodialyzer). The type of blood line for use is dependent upon the type of dialysis delivery system employed. | Cobe Hemaflo™ Disposable Blood Tubing Set is intended for use in hemodialysis treatment. | The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge. | The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge. |
| Currently in Distribution | NO | NO | YES | NO |
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Traditional 510(k) Gambro QuickSet® Bloodlines
| PREDICATE | PREDICATE | MODIFIED | MODIFIED | |
|---|---|---|---|---|
| G Series Blood Line | Hemaflo™ | DEVICE | DEVICE | |
| Blood Tubing | QuickSet® | QuickSet® | ||
| Set | Bloodlines | Bloodlines | ||
| [currently | [new models] | |||
| distributed] | ||||
| 009445601 | ||||
| 009558601 | ||||
| Catalogue No. | Not applicable | Not applicable | 009559601 | 009558714 |
| 018430501 | 009566714 | |||
| 018440501 | ||||
| 009566601 | ||||
| Arterial Chamber | Injection Molded | Injection Molded | Blow Molded | Injection Molded |
| Venous Chamber | Injection Molded | Injection Molded | Blow Molded | Injection Molded |
| Clamps | Pinch & Slide | Slide | Pinch | Pinch |
| Blood tubing | Soft PVC material | Soft PVC material | Soft PVC material | Soft PVC material |
| material | with DEHP | with DEHP | with DEHP | with DEHP-free |
| plasticizer | plasticizer | plasticizer | plasticizer | |
| Injection plug | Latex | Latex | Latex-free | Latex-free |
| material | (SEBS) | (SEBS) | ||
| Packaging | Blister | Pouch | Pouch | Blister |
| Quantity per box | 16 | 10 | 16 | 14 |
| Sterilization Method | ETO | Radiation | Radiation | Radiation |
| Expiration | 3 years | 3 years | 3 years | 3 years |
| Single Use | Yes | Yes | Yes | Yes |
| Storage | Between | Between | Between | Between |
| Temperature | 10°C (50°F) | 10°C (50°F) | 0°C (32°F) | 0°C (32°F) |
| and | and | and | and | |
| +24°C (75°F) | +24°C (75°F) | +30°C (86°F) | +30°C (86°F) |
Description and Conclusion of Testing
Nonclinical Testing:
The non-clinical testing consisted of performance testing (bench) that included biocompatibility testing, validation of the sterilization process, sterility testing, flow rate testing, validation of needle and needle-less system injection ports, compatibility testing with different hemodialysis machines, and testing for mechanical hemolysis.
Conclusion:
The successful non-clinical testing demonstrates the safety and effectiveness of the Gambro QuickSet® Bloodlines when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Thomas B. Dowell Regulatory Affairs Project Manager GAMBRO Renal Products 10810 West Collins Avenue LAKEWOOD CO 80215
JAN 3 0 2007
Re: K063290
Trade/Device Name: Gambro QuickSet® Bloodlines Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: October 31, 2006 Received: November 1, 2006
Dear Mr. Dowell:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary from 1906-2006. The letters "FDA" are in large bold font in the center of the logo. The word "Centennial" is written in cursive below the letters "FDA".
Protecting and Promoting Public Health
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Page 2 -
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063290
Device Name: Gambro QuickSet® Bloodlines
Indications for Use:
The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Nancy Brogdon
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
§ 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.