K Number
K100364
Device Name
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
Date Cleared
2010-11-03

(264 days)

Product Code
Regulation Number
876.5820
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System. The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.
Device Description
The Gambro Cartridge® Blood Set Low Weight – Low Volume is single use sterile tubing set employed in the Gambro hemodialysis equipments extracorporeal circulation. It conveys the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line) and it is commonly referred to as bloodline. A Gambro Cartridge® Blood Set Low Weight - Low Volume can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
More Information

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Not Found

No
The device description and performance studies focus on the physical components and mechanical performance of a blood tubing set for hemodialysis, with no mention of AI or ML.

No.
The device is a blood set used for hemodialysis, which conveys blood to and from a dialyzing filter, but it does not perform the therapeutic function itself. It is a component of a therapeutic system.

No

Explanation: The device is a "bloodline" used in hemodialysis to convey blood to and from a dialyzer for purification. It is a therapy delivery component, not a device that diagnoses a condition.

No

The device description clearly indicates it is a "single use sterile tubing set" and describes physical components like "tubing segments," "injection ports," and "tubing clamps." The performance studies also focus on physical properties and integrity. This is a hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic). Here's why:

  • Intended Use: The intended use is for hemodialysis treatment, which is a therapeutic procedure to filter blood outside the body. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The device is a tubing set used to convey blood during hemodialysis. It does not perform any diagnostic testing on the blood itself.
  • Lack of Diagnostic Function: There is no mention of the device analyzing blood components, detecting markers, or providing any diagnostic information.

The device is a medical device used in a therapeutic procedure, not a diagnostic one.

N/A

Intended Use / Indications for Use

The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System.

The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

Product codes (comma separated list FDA assigned to the subject device)

FJK

Device Description

The Gambro Cartridge® Blood Set Low Weight – Low Volume is single use sterile tubing set employed in the Gambro hemodialysis equipments extracorporeal circulation. It conveys the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line) and it is commonly referred to as bloodline. A Gambro Cartridge® Blood Set Low Weight - Low Volume can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The non-clinical testing consisted of performance testing (bench) that included testing for integrity of the strength between connections (pressure leak testing), flow rate (endurance testing of the pump segment), endurance testing of injection ports (access sites), priming volume assessment, tensile testing of joints and materials of all tubing segments, pressure transducers testing, tubing clamps testing, hemocompatibility testing, kinking resistance testing, hemodialysis delivery system compatibility, and expiration date testing (materials biocompatibility, performance, packaging integrity testing). No clinical testing was required or performed in support of this 510(K) submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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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.

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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.

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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

§ 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.

0

K100364

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401

Gambro Cartridge® Blood S10(k)
Gambro Cartridge® Blood Șet
Low Weight – Low Volume

NOV - 3 2010

510(K) SUMMARY

Submitter's NameGambro Renal Products, Inc.
Address14143 Denver West Parkway, Suite 400
Lakewood, CO 80401
Establishment
Registration Number2087532
Date of SummaryFebruary 8, 2010
Telephone Number
Fax Number(303) 222-6724
(303) 222-6919
Contact PersonKae Miller, Regulatory Affairs Manager
Name of the DeviceGambro Cartridge® Blood Set Low Weight - Low Volume
Catalogue Number:
003422-520
Common or Usual NameExtracorporeal blood circuit for hemodialysis
Classification NameClassification Name: Hemodialysis System and accessories
Device Class: II
Product Code: FJK
Regulation Number: 21 CFR 876.5820
Identification of the
Legally Marketed Device
(Predicate Device)Gambro Cartridge® Blood Set Low Weight
Catalogue Number: 003412-500
Classification Name: Hemodialysis System and accessories
Device Class: II
Product Code: FJK
Regulation Number: 21 CFR 876.5820

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1

K100364

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401

Traditional 510(k) Gambro Cartridge® Blood Set Low Weight - Low Volume

510(k) SUMMARY, continued

Device Description

The Gambro Cartridge® Blood Set Low Weight – Low Volume is single use sterile tubing set employed in the Gambro hemodialysis equipments extracorporeal circulation. It conveys the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line) and it is commonly referred to as bloodline. A Gambro Cartridge® Blood Set Low Weight - Low Volume can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

Indications For Use

The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System.

The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

Assessment of non-clinical performance data

The non-clinical testing consisted of performance testing (bench) that included testing for integrity of the strength between connections (pressure leak testing), flow rate (endurance testing of the pump segment), endurance testing of injection ports (access sites), priming volume assessment, tensile testing of joints and materials of all tubing segments, pressure transducers testing, tubing clamps testing, hemocompatibility testing, kinking resistance testing, hemodialysis delivery system compatibility, and expiration date testing (materials biocompatibility, performance, packaging integrity testing).

Assessment of clinical performance data

No clinical testing was required or performed in support of this 510(K) submission.

Conclusion

The successful testing demonstrates the safety and effectiveness of the Gambro Cartridge® Blood Sets Low Weight – Low Volume 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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2

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three thick, curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002

Ms. Kae Miller Regulatory Affairs Manager Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 LAKEWOOD CO 80401

NOV - 3 2010

Re: K100364

Trade/Device Name: Gambro Cartridge® Blood Set Low Weight - Low Volume Regulation Number: 21 CFR §876.5820

Regulation Name: Hemodialysis system and accessories

Regulatory Class: II

Product Code: FJK

Dated: October 20, 2010 Received: October 21, 2010

Dear Ms. Miller:

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, Drive, 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. Please note: CDRH does not evaluate information related to contract liality warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 on new with all the Act's requirements, including, but not limited to: registration and listing (21 CFP Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

3

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adverse events) (21 CFR 803); 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,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Hubert Lemon MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401

Traditional 510(k) Gambro Cartridge® Blood Set Low Weight - Low Volume

Indications for Use

510(k) Number (if known):

NOV - 3 2010

Device Name: Gambro Cartridge® Blood Set Low Weight - Low Volume

Indications for Use:

The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System.

The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

Prescription UseX
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K100364

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