ORBIT INFUSION SET

K130468 · Ypsomed AG · FPA · Mar 19, 2013 · General Hospital

Device Facts

• Record ID: K130468
• Device Name: ORBIT INFUSION SET
• Applicant: Ypsomed AG
• Product Code: FPA · General Hospital
• Decision Date: Mar 19, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Orbit Infusion Set facilitates subcutaneous delivery of fluids/medication from external infusion pump. Device consists of tubing, luer lock connector, adhesive base, and catheter. Tubing connects to medication reservoir; catheter inserts into subcutaneous tissue. Patented design allows 360° tubing rotation at adhesive attachment and disconnection of tubing set from infusion base. Used in clinical or home settings; operated by patients or healthcare providers. Output is delivery of medication to patient. Benefits include secure, flexible infusion site with rotational freedom to prevent tubing kinking.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against standards for material strength (ISO 9626), needle/catheter retention (ISO 10555-1, ISO 8536-8), pressure leak, penetration force, bond strength, and tape adhesion.

Technological Characteristics

Subcutaneous infusion set with luer lock, tubing, adhesive base, and catheter. Materials tested per ISO 9626 (steel cannula). Mechanical specifications: 20psi pressure leak resistance, <0.8N penetration force, >10N needle retention, >3N catheter retention, 15N tubing bond strength, 18N tape bond strength. 360° rotation mechanism. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring subcutaneous delivery of fluids and medication, such as insulin, via an external infusion pump.

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

• Talon Infusion Set (K033290)

Submission Summary (Full Text)

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# MAR 1 9 2013

# Summary of Safety and Effectiveness

"510(K) SUMMARY" -

Submitted By/ Contact Person:

Dr. Benjamin Reinmann Vice President Quality Management & Regulatory Affairs Ypsomed AG Brunnmattstrasse 6 CH - 3401 Burgdorf Switzerland Tel. [phone] Fax. [phone] E-mail: [e-mail]

## Date Prepared:

February 19, 2013

Orbit Infusion Set

Subcutaneous Infusion Set

Set, Administration, Intravascular

1.1. Trade/Proprietary Name:

1.2. Common/Usual Name:

1.3. Classification Name:

1.4. Classification:

l .5. Purpose of Submission:

1.6. Substantial Equivalence:

# 1.7. Device Description

Class: I I Panel: 80 Product Code: FPA 21 CFR 880.5440 Cite:

Yosomed acquired the Orbit infusion set business of ICU Medical Inc., USA in November 2011, including 510(k) K033290 under which the devices were cleared for marketing as the Talon Infusion Set. The purpose of this submission is to update the premarket notification file to reflect the product as manufactured. The only additional change is to modify the labeling to reflect Ypsomed, which previously had been a distributor of the product manufactured by ICU Medical.

The Orbit Infusion Sets are substantially equivalent to the Talon Infusion Set (K033290). The equivalence is supported by the attached documentation.

The Orbit Infusion Set is used for the subcutaneous delivery of fluids and medication from an external infusion pump.

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Orbit 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. These 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.

1.8. Intended Use:

The intended use of the modified device remains the same as the predicate device (Talon Infusion Set. K033290): Orbit Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

- 1.9. Technological Characteristics:
Orbit Infusion Sets are considered substantial equivalent to K033290. Talon Infusion Set, in intended use and in the device's operating principles.

1.10. Performance and Safety Data: Yosomed 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 Infusion Sets have met the requirements of the relevant sections of the following standards:

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

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| Occlusion test | No occlusion of the device when tested with a water<br>flow at a hydrostatic pressure of 0.1 bar |
|----------------|--------------------------------------------------------------------------------------------------------------|
| Tape adhesion | Removal of adhesive from a stainless steel plate<br>with a 90 degree peel force of minimum 2.5N<br>(0.56lbs) |

The verifications have shown evidence that the Orbit Infusion Sets meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product.

#### 1.11. Conclusion Ypsomed AG concludes based on the information presented that the modified product is substantially equivalent to the current product legally approved in the USA.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, with three curved lines representing its wings or body.

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

Dr. Beniamin Reinmann · Vice President Ypsomed AG Quality Management & Regulatory Affairs Brunnmattstrasse 6 Burgdorf Switzerland CH-3401

Re: K130468

Trade/Device Name: Orbit Infusion Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 22, 2013 Received: February 25, 2013

Dear Dr. Reinmann:

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.

March 19, 2013

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### Page 2 - Dr. Reinmann

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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K 130468

Device Name:

Indications For Use:

Orbit Infusion Sets

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

FDA

Richard C. Chapman 2013.03.18 15:38:51 -04'00'

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| Division of Anesthesiology, General Hospital |
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| Infection Control, Dental Devices |
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K130468 510(k) Number:

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