(242 days)
The Gambro Cartridge® Blood Set is intended for single use in a hemodialysis treatment using the Phoenix and Centrysystem 3 Dialysis Delivery Systems. The Low Weight model is used when a low extra-corporeal blood volume is recommended. The Low Weight model with a priming volume of 75 ml is indicated for patients with body weight greater than 20 Kg and lower or equal to 40 Kg. The standard models with a priming volume ranging from 103 ml to 162 ml are indicated for patients with body weight greater than 40 Kg.
The Gambro Cartridge® Blood Sets are single use sterile tubing sets employed in the Gambro 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) and they are commonly referred to as bloodlines. A Gambro Cartridge® Blood Set can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
The acceptance criteria and study details for the Gambro Cartridge® Blood Set are outlined below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing | Flow Rate | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating capability. The device's priming volumes are comparable to or slightly different from the predicate, but within expected ranges for hemodialysis blood sets. |
| Validation of System Injection Ports (Access Sites) | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating validation. | |
| Hemodialysis Machine Compatibility | Compatibility with Phoenix® and Centrysystem® 3 Dialysis Delivery Systems. | Predicate: The Cobe Cartridge Blood Tubing Set may be used with Gambro Dasco Phoenix, Gambro Model Cx, and Cobe Centrysystem 3 (and 3+) Systems. Modified Device: The Gambro Cartridge® Blood Set is intended for single use in a hemodialysis treatment using the Phoenix® and Centrysystem® 3 Dialysis Delivery Systems. (Matches predicate compatibility) | |
| Mechanical Hemolysis | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrated acceptable levels. | |
| Integrity of Strength Between Connections | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating integrity. | |
| Kink Resistance | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating resistance. | |
| Clamping of Tubing | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating proper clamping. | |
| Compliance with International Standards | Compliance with international standards applicable to extracorporeal blood circuits for hemodialyzers. | Successful non-clinical testing ensuring compliance. | |
| Biocompatibility | General Biocompatibility | Not explicitly stated as a numerical criterion, but implied that it should be safe for patient use. | Successful non-clinical testing demonstrating biocompatibility. Predicate: Soft PVC material. Modified Device: Soft PVC material with DEHP-free plasticizer (an improvement by being DEHP-free, which addresses a potential biocompatibility concern). Injection Plug Material: Latex-free (matches predicate, addressing allergen concerns). |
| Sterilization & Shelf Life | Expiration Dating | 3 years | Predicate: 3 years Modified Device: 3 years (Matches predicate). |
| Sterilization Method | Radiation | Predicate: Radiation Modified Device: Radiation (Matches predicate). | |
| Physical Attributes | Priming Volumes | Acceptable priming volumes based on intended patient weight categories (e.g., 75ml for patients 20-40 Kg, 103-162ml for patients >40 Kg). | Predicate: SN: 145 ml, DN: 103-120 ml, SNK: 45 ml, P: 75 ml. Modified Device: SN: 162 ml, DN: 103-119 ml, SNK: 45 ml, LW: 75 ml. (These appear to be within acceptable ranges for the specified patient populations, with slight variations from the predicate's ranges for some models, but the overall performance deemed equivalent). |
| Blood Tubing Length (Patient, Dialyzer venous, arterial) | Comparable to predicate lengths. | Predicate Patient Length: SN: 198 cm, DN: 183-244 cm, P: 183 cm. Modified Device Patient Length: SN: 198 cm, DN: 183-244 cm, LW: 183 cm. (Matches predicate) Predicate Dialyzer Length (venous): SN: 46 cm, DN: 46-53 cm, SNK: 46 cm, P: 46 cm. Modified Device Dialyzer Length (venous): SN: 46 cm, DN: 46-53 cm, SNK: 46 cm, LW: 46 cm. (Matches predicate) Predicate Dialyzer Length (arterial): SN: 46 cm, DN: 30-46 cm, SNK: 50 cm, P: 30 cm. Modified Device Dialyzer Length (arterial): SN: 46 cm, DN: 30-51 cm, SNK: 51 cm, LW: 30 cm. (Minor variations, but within general equivalence). | |
| Blood Tubing Thickness | Comparable to predicate thickness for blood pathway and blood pump segment. | Predicate Blood Pathway: SN-DN: 1.16 mm, P: 1.62 cm. Modified Device Blood Pathway: SN-DN: 1.16 mm, SN-DN Connections to dialyzer lines: 1.32 mm, LW: 1.63 mm. (Minor variations, but within general equivalence). Predicate Blood Pump Segment: SN-DN: 1.59 mm, P: 1.59 mm. Modified Device Blood Pump Segment: SN-DN: 1.59 mm, LW: 1.59 mm. (Matches predicate). | |
| General Safety & Effectiveness Statement | (Overall Conclusion) | The device is safe and effective for its defined indications for use and performs as well as or better than the legally marketed predicate device. | "The successful non-clinical testing demonstrates the safety and effectiveness of the Gambro Cartridge® Blood Set 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." |
2. Sample size used for the test set and the data provenance
The document mentions "non-clinical testing" and "performance testing (bench)" but does not specify numerical sample sizes for these tests.
The data provenance is from bench testing (laboratory studies), rather than clinical data from human patients. The country of origin of the data is not explicitly stated, but the submission is from Gambro Renal Products in Lakewood, CO, USA. 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 the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is non-clinical (bench testing) and does not inherently involve human expert consensus for "ground truth" in the way a clinical study or image interpretation study would. Performance criteria are likely established by engineering standards and regulatory requirements.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., imaging studies) to resolve discrepancies among experts. The described testing is non-clinical performance and engineering testing.
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
There was no MRMC comparative effectiveness study done. This submission is for a medical device (blood set), not an AI algorithm, and therefore such a study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" study (in the context of an algorithm) was not done because the device is not an algorithm. The testing performed was standalone for the device itself (bench testing) to assess its physical and functional properties against established engineering and safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's non-clinical testing would be based on engineering specifications, established performance standards (e.g., ISO standards for medical devices), regulatory requirements, and comparison to the predicate device's known performance characteristics. For example, the "truth" for flow rate would be a measured flow rate compared against a specified acceptable range, or the "truth" for biocompatibility would be determined by whether the materials passed standard biocompatibility tests.
8. The sample size for the training set
This information is not applicable/not provided as this is not an AI/machine learning device. The term "training set" is not relevant here.
9. How the ground truth for the training set was established
This information is not applicable/not provided as this is not an AI/machine learning device.
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K070414 Page 1 of 4
Gambro Traditional 510(k)
Gambro Cartridge® Blood Set
5.0 510(K) SUMMARY
007 1 2 2007
| Submitter's Name | Gambro Renal Products |
|---|---|
| Address | 10810 West Collins AvenueLakewood, CO 80215 |
| EstablishmentNumber | 2087532 |
| Date of Submission | February 9, 2007 |
| Contact Person | Thomas B. Dowell, Regulatory Affairs Project Manager |
| Telephone NumberFax Number | (303) 231-4094(303) 542-5138 |
| Name of the Device | Gambro Cartridge® Blood Set |
| Catalogue Numbers | 003409-400 Single Needle003409-410 Single Needle (with prime line attached)003410-500 Double Needle003410-510 Double Needle (with prime line attached)003410-710 Double Needle (with prime line attached with injection site)003411-500 Double Needle (with longer patient line)003412-500 Double Needle - Low Weight003414-500 Double Needle (with extended dialyzer line)003414-510 Double Needle (with extended dialyzer line and prime lineattached)003415-510 Double Needle (with prime line attached)003429-500 Single Needle Conversion Kit |
| Common or UsualName | Extracorporeal blood circuit for hemodialysers |
| Classification Name | Classification Name: Hemodialysis system and accessoriesDevice Class: IIProduct Code: KOCRegulation Number: 21 CFR 876.5820 |
| Identification of theLegally MarketedDevice(Predicate Device) | Cobe Cartridge Blood Tubing Set |
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K070914 Page 2 of 4
Traditional 510(k) Gambro Cartridge® Blood Set
510(k) SUMMARY, continued
The Gambro Cartridge® Blood Sets are single use sterile tubing sets Device Description employed in the Gambro 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) and they are commonly referred to as bloodlines. A Gambro Cartridge® Blood Set can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
Device Comparison Table
| PREDICATE | MODIFIED DEVICE | |
|---|---|---|
| Cobe Cartridge Blood Tubing Set | Gambro Cartridge® Blood Set | |
| Indication for Use | The Cobe Cartridge Blood Tubing Setmay be used with the followinghemodialysis devices: The GambroDasco Phoenix; The Gambro Model Cx,and the Cobe Centrysystem 3 (and 3+)Systems. | The Gambro Cartridge® Blood Set isintended for single use in ahemodialysis treatment using thePhoenix® and Centrysystem® 3Dialysis Delivery Systems. The LowWeight model is used when a lowextra-corporeal blood volume isrecommended. The Low Weightmodel with a priming volume of 75ml is indicated for patients with bodyweight greater than 20 Kg and loweror equal to 40 Kg. The standardmodels with a priming volumeranging from 103 ml to 162 ml areindicated for patients with bodyweight greater than 40 Kg. |
| Catalogue No. | Single Needle (SN):003409-400003409-410Double Needle (DN):003410-500003410-510003411-500003414-500Single Needle conversion kit (SNK):003429-500Double Needle Pediatric (P):003412-500 | Single Needle (SN):003409-400003409-410Double Needle (DN):003410-500003410-510003411-500003414-510003414-500003415-510003410-710Single Needle conversion kit (SNK):003429-500Double Needle Low Weight (LW):003412-500 |
| PREDICATE | MODIFIED DEVICE | |
| Cobe Cartridge Blood Tubing Set | Gambro Cartridge® Blood Set | |
| Cartridge | Yes | Yes |
| Dialysis MachineCompatibility (U.S.) | Phoenix and Centrysystem 3 | Phoenix and Centrysystem 3 |
| Clamps | Pinch | Pinch |
| Blood TubingMaterial | Soft PVC material | Soft PVC material with DEHP-freeplasticizer |
| Blood Tubing Length | Patient length:SN: 198 cmDN: from 183 cm to 244 cmP: 183 cm | Patient length:SN: 198 cmDN: from 183 cm to 244 cmLW: 183 cm |
| Dialyzer length (venous):SN: 46 cmDN: from 46 cm to 53 cmSNK: 46 cmP: 46 cm | Dialyzer length (venous):SN: 46 cmDN: from 46 cm to 53 cmSNK: 46 cmLW: 46 cm | |
| Dialyzer length (arterial):SN: 46 cmDN: from 30 cm to 46 cmSNK: 50 cmP: 30 cm | Dialyzer length (arterial):SN: 46 cmDN: from 30 cm to 51 cmSNK: 51 cmLW: 30 cm | |
| Blood TubingThickness | Blood Pathway:SN-DN: 1.16 mmP: 1.62 cm | Blood Pathway:SN-DN: 1.16 mmSN-DN Connections to dialyzerlines: 1.32 mmLW: 1.63 mm |
| Blood Pump segment:SN-DN: 1.59 mmP: 1.59 mm | Blood Pump segment:SN-DN: 1.59 mmLW: 1.59 mm | |
| Priming Volumes | SN: 145 mlDN: from 103 ml to 120 mlSNK: 45 mlP: 75 ml | SN: 162 mlDN: from 103 ml to 119 mlSNK: 45 mlLW: 75 ml |
| Injection PlugMaterial | Latex-free | Latex-free |
| Packaging | Pouch | Blister |
| Sterilization Method | Radiation | Radiation |
| Expiration | 3 years | 3 years |
| Single Use | Yes | Yes |
| Storage Temperature | -18°C (0°F) and 49°C (120°F) | -18°C (0°F) and 49°C (120°F) |
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K070 4/7 page 3 of 4
Gambro Cartridge® Blood Set
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KO70 4/4 P392 4 of 4
Traditional 510(k) Gambro Cartridge® Blood Set
Description and Conclusion of Testing
Nonclinical Testing:
The non-clinical testing consisted of performance testing (bench) that included testing for biocompatibility, flow rate, validation of system injection ports (access sites), hemodialysis machine compatibility, mechanical hemolysis, expiration dating, integrity of the strength between connections, kink resistance, clamping of tubing and testing required by process to ensure compliance with other international standards applicable to extracorporeal blood circuit for hemodialysers.
Conclusion:
The successful non-clinical testing demonstrates the safety and effectiveness of the Gambro Cartridge® Blood Set 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/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 1 2 2007
Mr. Thomas B. Dowell Quality Systems Program Manager Gambro® Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215
Re: K070414
Trade/Device Name: Gambro Cartridge® Blood Set Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: July 9, 2007 Received: July 10, 2007
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 Eederal Register.
Image /page/4/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in it. The logo is black and white and has a star design at the bottom. The text is arranged in a circular fashion around the central FDA letters.
Protecting and Promoting Public Health
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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. Hogdon
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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Traditional 510(k) Gambro Cartridge® Blood Set
Indications for Use
510(k) Number (if known): K070414
Device Name: Gambro Cartridge® Blood Set
Indications for Use:
The Gambro Cartridge® Blood Set is intended for single use in a hemodialysis treatment using the Phoenix and Centrysystem 3 Dialysis Delivery Systems. The Low Weight model is used when a low extra-corporeal blood volume is recommended. The Low Weight model with a priming volume of 75 ml is indicated for patients with body weight greater than 20 Kg and lower or equal to 40 Kg. The standard models with a priming volume ranging from 103 ml to 162 ml are indicated for patients with body weight greater than 40 Kg.
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)
Halut Peunand
(Division Si(i-Uff)
Page 17 of 57
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K070414
§ 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.