Orbit Inserter

K163400 · Ypsomed AG · KZH · Jul 26, 2017 · General Hospital

Device Facts

• Record ID: K163400
• Device Name: Orbit Inserter
• Applicant: Ypsomed AG
• Product Code: KZH · General Hospital
• Decision Date: Jul 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2

Intended Use

The Orbit Inserter is intended to be used to assist patients and their caregivers by providing a mechanism to automate the insertion of compatible Ypsomed Infusion Sets primarily in a home setting.

Device Story

Orbit Inserter is a manually operated, spring-loaded insertion aid for automatic insertion of compatible Ypsomed infusion sets; assists user with cannula insertion into subcutaneous tissue. Device is non-invasive, non-sterile, and intended for multiple uses by same patient. Constructed of plastic with stainless-steel spring. Used primarily in home setting by patients or caregivers. User manually activates device via button to trigger spring-driven insertion mechanism. Simplifies infusion set placement; ensures consistent insertion depth/angle; reduces user error during subcutaneous access.

Clinical Evidence

Bench testing only. Performance verified through dimensional and functional testing (activation torque, button force, insertion force, reset torque) initially and after 550 activations. Biocompatibility confirmed per ISO 10993-5. Summative human factors (HF) validation performed to confirm safe use by intended user groups without formal training.

Technological Characteristics

Manually actuated, spring-driven insertion device. Materials: plastic housing, metal spring. Dimensions/form factor: handheld. Connectivity: none. Sterilization: non-sterile. Software: none. Energy source: mechanical (spring).

Indications for Use

Indicated for patients and caregivers to aid in the insertion of the cannula into the subcutaneous tissue for compatible infusion sets listed on the labeling.

Regulatory Classification

Identification

A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

Predicate Devices

• Quick-serter

Submission Summary (Full Text)

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## 510(k) Summary for K163400

| Submitted By/<br>Contact Person: | Stephan Affolter<br>Head of Quality System & Regulatory Affairs<br>Ypsomed AG<br>Brunnmattstrasse 6<br>CH - 3401 Burgdorf<br>Switzerland<br>Tel. [phone]<br>Fax [phone]<br>E-mail: [e-mail] |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternative Contact: | Lee Leichter<br>President<br>P/L Biomedical<br>10882 Stonington Avenue<br>Fort Myers, FL 33913<br>USA<br>Tel. [phone]<br>Fax. [phone]<br>E-mail: [e-mail] |
| Date Prepared: | July 24, 2017 |
| 1.1. Trade/Proprietary Name: | Orbit Inserter |
| 1.2. Common/Usual Name: | Spring loaded insertion device |
| 1.3. Classification Name: | Introducer, syringe needle |
| 1.4. Classification:<br>Panel:<br>Product Code:<br>Regulation Number: | Class: II<br>80<br>KZH<br>21 CFR 880.6920 |
| 1.5. Purpose of Submission: | To introduce an optional inserter for Orbit Infusion<br>Sets to the marketplace. |
| 1.7. Device Description | The Orbit Inserter is a manually operated, spring-<br>loaded insertion aid for automatic insertion of<br>compatible Orbit infusion sets. It assists the user with<br>insertion of the infusion set cannula into the<br>subcutaneous tissue.<br>The device is non-invasive, non-sterile and intended<br>for multiple uses by the same patient. The Orbit<br>Inserter is made of plastic and is powered by a<br>stainless-steel spring. |
| 1.8. Indication for Use: | The Orbit Inserter is indicated to aid the user with the<br>insertion of the cannula into the subcutaneous tissue<br>for compatible infusion sets listed on the labeling. |
| 1.9. Intended Use: | The Orbit Inserter is intended to be used to assist<br>patients and their caregivers by providing a<br>mechanism to automate the insertion of compatible<br>Ypsomed Infusion Sets primarily in a home setting. |

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#### 1.10. Technological Characteristics:

The technological characteristics of the Orbit Inserter are the same as for the predicate devices (no significant change in the materials, design, energy source), they all are manually actuated and use a spring to provide the energy (force) to automatically insert the infusion set cannula into the infusion site.

| Characteristic | Orbit Inserter | Quick-serter | Comments |
|-------------------------------|-----------------------------------|------------------------------------|-----------------------------------------------------------|
| <b>Material of components</b> | | | |
| Inserter | Plastic | Plastic | Same |
| Spring | Metal | Metal | Same |
| <b>Design/Energy Source</b> | | | |
| Energy Source | Spring-driven device | Spring-driven device | Same |
| Method of Activation | Manual Activation with One button | Manual Activation with Two buttons | Different mechanism to activate the device |
| Lifetime | 2 years | 3 years | Different, validated Lifetime claim is company preference |

#### 1.11. Performance Data:

Ypsomed has verified the Dimensional and functional specifications initially and after 550 activations. Biocompatibility was also tested and confirmed. A Summative user validation was performed confirming that the device could be used safely by the intended user groups after reading the instructions for use and without formal training.

The verifications have shown evidence that the Orbit Inserter meets the acceptance criteria of the performance requirements. Based on the results it can be concluded that the device performance is acceptable for the product.

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| Test | Specification | Results |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimensional | Devices must meet Dimensional Specification | Pass |
| Visual<br>inspection | No cracking<br>No gross discoloration | Pass |
| Functional<br>Testing | Meets Functional Specifications for:<br>• Activation Torque<br>• Button Activation force<br>• Insertion Force<br>• Reset Torque | Pass |
| Biological | ISO 10993-5, Biological evaluation of medical devices -<br>Part 5: Tests for in vitro cytotoxicity | Pass |
| Usability | Successful Summative HF Validation | Pass |
| Life-cycle<br>Testing | Meets Visual and Functional requirements after 550 activations | Pass |

#### 1.12. Conclusion

Ypsomed AG concludes based on the information presented that the product is substantially equivalent to the predicate devices legally marketed in the USA.

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

July 26, 2017

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

Re: K163400

Trade/Device Name: Orbit Inserter Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe needle introducer Regulatory Class: Class II Product Code: KZH Dated: June 28, 2017 Received: June 29, 2017

Dear 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. Iisting 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

Sincerely,

for Michael Ryan Acting 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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### Change Control Table, Change History

#### Change Control Table

| Version | Document Author | Document Approver | Date Approved |
|---------|---------------------|---------------------|---------------|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |

Complete Change Control Table (all versions) retained in SWIFT Docs.