Orbit Infusion Set

K150921 · Ypsomed AG · FPA · Apr 12, 2016 · General Hospital

Device Facts

• Record ID: K150921
• Device Name: Orbit Infusion Set
• Applicant: Ypsomed AG
• Product Code: FPA · General Hospital
• Decision Date: Apr 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

Device Story

Orbit®micro Infusion Set is a subcutaneous infusion device for external insulin pumps. It consists of tubing with a luer lock connection to a medication reservoir and an adhesive base that anchors a stainless steel indwelling cannula into subcutaneous tissue. A patented design allows 360° tubing rotation at the adhesive site and disconnection of the tubing from the infusion base. The device is used by patients in home or clinical settings to deliver medication. It replaces the soft Teflon cannula of the predicate device with a stainless steel cannula. The healthcare provider or patient attaches the device to the skin; the cannula delivers medication from the pump. The device facilitates continuous subcutaneous insulin infusion, potentially improving glycemic control for patients requiring insulin therapy.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was established through bench testing, including material strength, pressure leak, penetration force, needle/catheter retention, bond strength, and tape adhesion. Biocompatibility testing included cytotoxicity, hemolysis, acute systemic injection, sensitization, intracutaneous reactivity, and bacterial endotoxin testing.

Technological Characteristics

Subcutaneous infusion set with stainless steel cannula (31G or 27G). Components: PVC/LDPE tubing, MABS caps, polyisoprene septum, nonwoven medical tape, PC base. Sterilization: Ethylene Oxide. Connectivity: Mechanical luer lock. Standards: ISO 9626 (cannula strength), ISO 10555-1 (needle retention), ISO 8536-8 (catheter retention), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for subcutaneous delivery of fluids and medication (e.g., insulin) from an external infusion pump in patients requiring such therapy.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Orbit Infusion Set (K130468)

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

April 12, 2016

Ypsomed AG % Lee Leichter President P/L Biomedical 10882 Stonington Avenue Fort Myers, Florida 33913

Re: K150921

Trade/Device Name: Orbit®micro Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 8, 2016 Received: March 11, 2016

Dear Mr. Lee Leichter:

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.

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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); 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/Resourcesfor You/Industry/default.htm. 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 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.

# Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K150921

Device Name Orbit®micro Infusion Set

Indications for Use (Describe)

Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(K) SUMMARY for K150921

| Submitted By/ Contact Person: | Stephan Affolter<br>Head of Quality System & Regulatory Affairs<br>Ypsomed AG<br>Brunnmattstrasse 6<br>3401 Burgdorf<br>Switzerland<br>Tel. [phone]<br>Fax [phone]<br>E-mail: <a href="mailto:[e-mail]">[e-mail]</a> |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternative Contact: | Lee Leichter<br>President<br>P/L Biomedical 10882 Stonington Avenue<br>Fort Myers, FL 33913<br>USA<br>Tel. [phone]<br>Fax. [phone]<br>E-mail: <a href="mailto:[e-mail]">[e-mail]</a> |
| Date Prepared: | March 08, 2016 |
| 1. Trade/Proprietary Name: | Orbit ^® micro Infusion Set |
| 2. Common/Usual Name: | Subcutaneous Infusion Set |
| 3. Classification Name: | Intravascular Administration Set |
| Classification: | Class: II<br>Panel: 80<br>Product Code: FPA<br>Regulation: 21 CFR 880.5440 |

- 4. Predicate Device: K130468 Orbit Infusion Set
- 5. Purpose of Submission:

To market a product line of subject devices, designed with stainless steel cannulas as an alternative to the predicate devices designed with soft catheters and stainless steel insertion needles.

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- 6. Device Description
All Orbit micro Infusion Sets are used for the subcutaneous delivery of fluids and medication from an external infusion pump. All Orbit micro Infusion sets are comprised of tubing that is connected on one end to the medication reservoir of the infusion pump using a luer lock connection and on the other end to the patient, attached to the skin by an adhesive base, anchoring a catheter that is inserted into the subcutaneous tissue. All Orbit micro Infusion sets have a patented design feature which allows the tubing to freely rotate 360° at the adhesive attachment and to disconnect the tubing set from the infusion base. The subject devices use a stainless steel indwelling cannula instead of the Teflon cannula in the predicate devices.

- 7. Intended Use:
The intended use of the subject devices remains the same as the predicate devices (K130468):

Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

- 8. Technological Characteristics:
The technological characteristics of the subject devices are the same as for the predicate devices (K130468). There are some changes in components, materials and dimensions. All significant differences are described below.

Otherwise the Subject devices have the same indications for use, intended use and the same design including connectors, tubing lengths and diameters, materials, dimensions and operating principles as the currently marketed predicate devices.

| Characteristic | Predicate device | Subject device | Comments |
|------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Dimensions | | | |
| Cannula Diameter | Soft Cannula:<br>ID 0.44mm<br>OD 0.76mm<br><br>Introducer Needle:<br>ID 0.20 mm<br>OD 0.41 (27G) | Stainless steel cannula (31G):<br>ID 0.11 mm<br>OD 0.25 mm<br><br>Stainless steel cannula (27G):<br>ID 0.24 mm<br>OD 0.41 mm | Different<br>dimensions |
| Cannula Length | 6mm, 9mm | 5.5mm, 8mm, 8.5mm | Different<br>dimensions |
| Tubing Length | 30cm (12 inch) - 105cm (42 inch) | 30cm (12 inch) - 105cm (42 inch) | Identical |
| Tubing Diameter | 0.020 x 0.062 inch (0.51 x 1.57mm ) | 0.020 x 0.062 inch (0.51 x 1.57mm ) | Identical |
| Material of components | | | |
| Female Luer | PVC | PVC | Identical |
| Tubing | PVC - outer layer<br>PE Polyethylene (LDPE) - inner<br>layer<br>co-extruded | PVC - outer layer<br>LDPE - inner layer co-extruded | Identical |
| Cap, Tubing | MABS | MABS | Identical |
| Septum | Polyisoprene | Polyisoprene | Identical |
| Adhesive Tape | Nonwoven Medical Tape | Nonwoven Medical Tape | Identical |
| Base | PC | PC | Identical |
| Cap, Needle | MABS | MABS | Identical |
| Lubrication | Silicon | Silicon | Identical |
| Needle Protector | HDPE/LDPE | HDPE/LDPE | Identical |
| Tape | Cohesive Tape | Cohesive Tape | Identical |

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| Metal anchor<br>(Eyelet) | Stainless Steel | N/A | N/A |
|--------------------------|-------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Introducer Needle | Stainless Steel | N/A | N/A |
| Blue needle cover | HDPE/LDPE | N/A | N/A |
| Characteristic | Predicate device | Subject device | Comments |
| Catheter / Cannula | FEP catheter | Stainless Steel cannula | Different material<br>for the cannula,<br>but the same<br>stainless steel as<br>for the introducer<br>needle of the<br>subject device |
| UV Glue bond | Adhesive | Adhesive | Same type of<br>adhesive (acrylic<br>urethane adhesive,<br>UV-cured),<br>different viscosity |
| Packaging Material | | | |
| Primary Packaging | Blister sealed with Tyvek lid | Blister sealed with Tyvek lid | Identical |
| Sterilization | | | |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |

#### 9. Performance Data

Y psomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices. The Orbit®micro Infusion Sets have met the requirements of the relevant sections of the following standards:

| Test | Specification | Results |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------|
| Material strength<br>of steel cannula | Material strength per ISO 9626 | Pass |
| Activated pressure leak | No leak when subjected to pumping pressures up to 20psi<br>under normal delivery conditions and occluded fluid path<br>conditions | Pass |
| Penetration force | Needle and catheter shall penetrate a 0.025 inch thick<br>membrane with a speed of 50mm/min. and a force of less<br>than 0.8N | Pass |
| Needle retention | No separation of the needle from the cap when subjected to<br>a minimum force of 10N (ISO 10555- 1, Annex B) | Pass |
| Catheter retention | No separation of the catheter from the base when<br>subjected to a minimum force of 3N (ISO 8536-8) | Pass |
| Bond strength of<br>tubing/fittings | No separation of the tubing assembly when subjected to a<br>static tensile force of 15N for 15 sec. | Pass |
| Bond strength of<br>tape/base | No separation of the tape from the base when subjected to<br>a minimum force of 18N | Pass |
| Engagement force<br>tubing cap/base | The cap locks on the base with a force less than 13N | Pass |

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| Disengagement force<br>tubing cap/base | The force to remove the tubing cap from the base is more<br>than 13N | Pass |
|----------------------------------------|------------------------------------------------------------------------------------------------------------|------|
| Occlusion test | No occlusion of the device when tested with a water flow<br>at a hydrostatic pressure of 0.1 bar | Pass |
| Tape adhesion | Removal of adhesive from a stainless steel plate with a 90<br>degree peel force of minimum 2.5N (0.56lbs) | Pass |

The following biocompatibility tests were completed on the subject device in accordance to ISO 10993-1 2009 with acceptable results:

- · Cytotoxicity ISO MEM Elution Assay
- Hemolysis ASTM Assay Extract Method
- · Acute Systemic Injection
- Guinea Pig Maximization Sensitization
- Intracutaneous reactivity study ●
- . Bacterial Endotoxin

The Subject infusion sets were tested, and met all acceptance criteria, for all the requirements as provided above. Based on the results Ypsomed concluded that the device performance is acceptable for the product.

#### 10. Clinical Data

Clinical Data per 807.92(b)(2) was not required to establish substantial equivalence for these devices.

#### 11. Conclusion

Y psomed AG concludes based on the information presented that the subject infusion sets are substantially equivalent to the predicate device legally marketed in the US.