Oxyless Blood Tubing Set

K150304 · Oxyless, Ltd. · FJK · Feb 24, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K150304
• Device Name: Oxyless Blood Tubing Set
• Applicant: Oxyless, Ltd.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Feb 24, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oxyless Blood Tubing Set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodialyzer. The compatibility of available configurations is the responsibility of the physician in charge.

Device Story

The Oxyless Blood Tubing Set is a disposable, sterile, single-use extracorporeal circuit component. It transports blood from a patient's access point to a hemodialyzer and returns it to the patient. The set includes arterial and venous lines, pump tubing, air trap chambers, pressure monitoring lines, injection ports, service lines, and tubing clamps. It is designed for use with various hemodialysis machines (e.g., Fresenius, Nikkiso, B. Braun, Gambro). The device is operated by healthcare professionals in clinical settings. By facilitating the extracorporeal circuit, it enables hemodialysis treatment for patients with renal failure.

Clinical Evidence

No clinical data was submitted or relied upon. Substantial equivalence is supported by bench testing only, including pressure leak, pump segment endurance, injection port endurance, priming volume, tensile testing, transducer leak, clamp performance, kink resistance, and operational testing with blood analog fluid. Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and pyrogenicity) was performed per ISO 10993.

Technological Characteristics

Materials: PVC, PC, PP, PTFE, silicone; DEHP-free. Components: pump tubing, air trap chambers, pressure monitoring lines, injection ports, service lines, tubing clamps. Sterile, single-use. No energy source (passive fluid path).

Indications for Use

Indicated for patients requiring extracorporeal blood access during hemodialysis treatment. Compatible with medically prescribed hemodialyzers; configuration selection is determined by the physician in charge.

Regulatory Classification

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.

Predicate Devices

• Nipro Blood Tubing Set (K072024)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 23, 2016

Oxyless Ltd. % Bob Duffy President Bob Duffy Associates 16405 Summer Sage Road Poway, CA 92064

Re: K150304

Trade/Device Name: Oxyless Blood Tubing Set Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FJK Dated: January 28, 2016 Received: January 29, 2016

Dear Bob Duffy.

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. Please note: CDRH does not evaluate information related to contract liability 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.

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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); medical device reporting (reporting of medical device-related 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150304

Device Name Oxyless Blood Tubing Set

#### Indications for Use (Describe)

The Oxyless Blood Tubing set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodiality of available configurations is the responsibility of the physician in charge.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <span style="font-weight: bold;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </span> |

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### 510(k) Summary Oxyless Blood Tubing Set

### 21CFR 807.92 (a)(1) SUBMITTER

Submitter Name: Oxyless LTD Submitter Address: Bewlay House 2 Swallow Place London W1B 2AE UK Submitter Telephone Number: [phone] Contact Person: Bob Duffy President Bob Duffy Associates 16405 Summer Sage Road Poway, California 92064 858-487-1859 [e-mail] 510(K) Summary prepared: 2/22/2016

21CFR 807.92 (a)(2) DEVICE NAME

# 21CFR 807.92 (a)(2) DEVICE NAME

Trade Name: Oxyless Blood Tubing Set Common Name: Hemodialysis Blood Tubing Set Classification Name: Hemodialysis System and Accessories Product Code: FJK

### 21CFR 807.92 (a)(3) PREDICATE DEVICE

The predicate for the Oxyless Blood Tubing Set is the:

#### Nipro Blood Tubing Set cleared under 510(k) K072024:

- a. Device Proprietary Name: Blood Tubing Set with Transducer Protector and Priming Set
- b. Manufacturer: Nipro Medical Corporation
- c. Product Code: FJK
- d. Indications for Use: Disposable blood lines intended to provide extracorporeal access to the patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

The basis for the Oxyless Blood Tubing Set Abbreviated 510(k) submission is for a new device.

## 21CFR 807.92 (a)(4) DEVICE DESCRIPTION

The Oxyless Blood Tubing Set is a hemodialysis blood tubing set designed to transport blood from a patient for acute or chronic hemodialysis treatment from the point of access to the dialyzer fixed to the hemodialysis machine and returning to the patient to complete the extracorporeal circuit. The tubing line components are preconfigured and packaged as an arterial line, a venous line and in some configurations, a priming line, for use with various dialysis machines from Fresenius, Nikkiso, B. Braun and Gambro.

The components of the Oxyless Blood Tubing Set include pump tubing, air trap

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chambers, pressure monitoring lines, injection ports, service lines and tubing clamps.

Major materials used for the various components of the Oxyless Blood Tubing Set are polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP), polytetrafluoroethylene (PTFE) and silicone. The device is DEHP-free.

Each Oxyless Blood Tubing Set is packaged as sterile and for single use only. It is for prescription use only on the order of a healthcare professional.

## 21CFR 807.92 (a){5) INDICATIONS FOR USE/INTENDED USE

The Oxyless Blood Tubing Set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodialyzer. The compatibility of available configurations is the responsibility of the physician in charge.

### 21CFR 807.92 (a)(6) COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Oxyless Blood Tubing Set with transducer protector and optional priming set has the same technological characteristics (i.e. design, material, chemical composition. energy source) as the predicate device identified above. The following table provides a summary of the technological characteristics of the new device in comparison to those of the predicate device.

| Category | Oxyless Blood Tubing Set<br>New Device | Nipro Blood Tubing Set<br>Predicate Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Trade Name | Oxyless® Set - Blood<br>Tubing Set with Transducer<br>Protector and optional<br>Priming Set | Nipro® Set - Blood Tubing<br>Set with Transducer<br>Protector and Priming Set |
| 2. Model Number | LK36355RO, LK76154RO,<br>LK14529RO, LK46451RO,<br>CK84-14-B, CK84-14-C,<br>CK84-14-D, CK84-14-E | A201-A219, V801-V806,<br>5M9634, 5M9693 |
| 3. 510(k) submitter/holder | Oxyless Ltd. | Nipro Medical Corporation |
| 4. Manufacturer | Oxyless Ltd. | Nipro Medical Corporation |
| 5. 510(k) Number | K150304 | K072024 |
| 6. Regulation Number | 21 CFR 876.5820 | 21 CFR 876.5820 |
| 7. Regulation Name | Hemodialysis system and<br>accessories | Hemodialysis system and<br>accessories |
| 8. Regulatory Class | Class II | Class II |
| Category | Oxyless Blood Tubing Set<br>New Device | Nipro Blood Tubing Set<br>Predicate Device |
| 9. Product Code | FJK | FJK |
| 10. Intended Use/Indications<br>for Use | The Oxyless Blood Tubing<br>Set with transducer protector<br>and optional priming set<br>comprises disposable blood<br>tubing lines intended to<br>provide extracorporeal access<br>to the patient's blood during<br>hemodialysis. This blood<br>tubing set is indicated for use<br>with a medically prescribed<br>hemodialyzer. The<br>compatibility of available<br>configurations is the<br>responsibility of the<br>physician in charge. | Disposable blood tubing<br>lines intended to provide<br>extracorporeal access to the<br>patient's blood during<br>hemodialysis. The<br>compatibility of available<br>configurations is the<br>responsibility of the<br>physician in charge. |
| 11. Device design | Blood Tubing lines<br>configured as:<br>1. Arterial line<br>2. Venous line<br>3. Priming line (on<br>some models) | Blood Tubing lines<br>configured as:<br>1. Arterial line<br>2. Venous line<br>3. Priming line (on<br>some models) |
| 12. Blood Tubing Set<br>Components | Tubing, air trap chambers,<br>pressure monitoring lines,<br>service lines, injection ports<br>and tubing clamps | Tubing, air trap chambers,<br>pressure monitoring lines,<br>service lines, injection ports<br>and tubing clamps |
| 13. Sterility | Sterile | Sterile |
| 14. Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| 15. Single use or reuse | Single use | Single use |

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In summary, the comparison demonstrates that the Oxyless Blood Tubing Set is substantially equivalent to the Predicate device.

# 21CFR 807.92 (b)(1) NON-CLINICAL TESTING

Bench performance testing of the Oxyless Blood Tubing Set was conducted and compared to the predicate device to support substantial equivalence, in accordance with the performance testing described in the FDA Guidance for Hemodialysis Blood Tubing Sets. This testing consisted of:

- 1. pressure leak testing

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- 2. pump segment endurance testing
- 3. injection port endurance testing
- 4. priming volume assessment
- 5. tensile testing of joints and materials of all tubing segments
- 6. pressure transducers leak testing
- 7. clamp performance testing
- 8. tubing kink resistance
- 9. blood tubing set operational testing with a blood analog fluid for four hours at 37°C

Biocompatibility testing, similar to that performed on the predicate device for its 501(k) submission, was conducted as described in "Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The following suggested tests were conducted and demonstrate that the materials in the Oxyless Blood Tubing Set are biocompatible for its Intended Use:

- . Cytoxicity
- Sensitization .
- . Irritation or Intracutaneous Reactivity
- System Toxicity (Acute)
- Genotoxicity ●
- Hemocompatibility and Hemolysis ●
- Pyrogenicity ●

# 21CFR 807.92 (b)(2) CLINICAL TESTING

No clinical tests are submitted, referenced, or relied on in this premarket notification submission for a determination of substantial equivalence.

## 21CFR 807.92 (b)(3) CONCLUSIONS FROM NON-CLINICAL TESTS

The results of the performance testing of both the Oxyless Blood Tubing Set and the predicate device meet the acceptance criteria for all tests. The results of the testing also demonstrate that the Oxyless Blood Tubing Set is as safe, as effective and performs as well as the legally marketed predicate device, thus demonstrating substantial equivalence. Biocompatibility testing for the Oxyless Blood Tubing Set, similar to that conducted for the predicate device, demonstrates that the materials used are biocompatible for its intended use.