The Orbit Inserter is indicated to aid the user with the insertion of the cannula into the subcutaneous tissue for compatible infusion sets listed on the labeling.

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 Description

The Orbit Inserter is a manually operated, spring-loaded insertion aid for automatic insertion of compatible Orbit infusion sets. It assists the user with insertion of the infusion set cannula into the subcutaneous tissue. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The Orbit Inserter is made of plastic and is powered by a stainless-steel spring.

AI/ML Overview

This document is a 510(k) Summary for the Orbit Inserter, a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or algorithms, nor does it present data from diagnostic imaging studies or multi-reader multi-case studies typically associated with AI performance evaluations.

Therefore, many of the requested points in your prompt are not applicable to the content of this document. I will answer the applicable questions and explain why others do not apply based only on the provided text.

Here's a breakdown of the acceptance criteria and study information for the Orbit Inserter based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (Specification)	Reported Device Performance (Results)
Dimensional	Devices must meet Dimensional Specification	Pass
Visual Inspection	No cracking; No gross discoloration	Pass
Functional Testing	Meets Functional Specifications for: • Activation Torque • Button Activation force • Insertion Force • Reset Torque	Pass
Biological	ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Pass
Usability	Successful Summative HF Validation	Pass
Life-cycle Testing	Meets Visual and Functional requirements after 550 activations	Pass

2. Sample size used for the test set and the data provenance

The document mentions "after 550 activations" for Life-cycle Testing, which implies a sample size of at least one device tested for 550 activations. It doesn't explicitly state the number of devices or the data provenance (country of origin, retrospective/prospective). However, the company, Ypsomed AG, is based in Switzerland.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The device is a mechanical inserter, not an AI or diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" here is the device's physical performance according to engineering and usability specifications.

4. Adjudication method for the test set

This is not applicable. As it's a mechanical device performance test, there's no need for adjudication by multiple experts in the sense of agreeing on a diagnosis or marking a lesion. The results are objective measurements and observations against pre-defined specifications.

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

This is not applicable. This document describes a mechanical medical device, not an AI system. Therefore, no MRMC study, human readers, or AI assistance is relevant to its performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a mechanical inserter; there is no algorithm or AI component to test in a standalone manner.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and ISO standards for mechanical, visual, functional, and biological properties, as well as summative user validation for usability. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a mechanical device. This concept applies to machine learning models.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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510(k) Summary for K163400

Submitted By/Contact Person:	Stephan AffolterHead of Quality System & Regulatory AffairsYpsomed AGBrunnmattstrasse 6CH - 3401 BurgdorfSwitzerlandTel. 0041-34 424 3382Fax 0041-34 424 4122E-mail: stephan.affolter@ypsomed.com
Alternative Contact:	Lee LeichterPresidentP/L Biomedical10882 Stonington AvenueFort Myers, FL 33913USATel. (239) 244-1448Fax. (815) 550-0162E-mail: leichter@plbiomedical.com
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:Panel:Product Code:Regulation Number:	Class: II80KZH21 CFR 880.6920
1.5. Purpose of Submission:	To introduce an optional inserter for Orbit InfusionSets to the marketplace.
1.7. Device Description	The Orbit Inserter is a manually operated, spring-loaded insertion aid for automatic insertion ofcompatible Orbit infusion sets. It assists the user withinsertion of the infusion set cannula into thesubcutaneous tissue.The device is non-invasive, non-sterile and intendedfor multiple uses by the same patient. The OrbitInserter is made of plastic and is powered by astainless-steel spring.
1.8. Indication for Use:	The Orbit Inserter is indicated to aid the user with theinsertion of the cannula into the subcutaneous tissuefor compatible infusion sets listed on the labeling.
1.9. Intended Use:	The Orbit Inserter is intended to be used to assistpatients and their caregivers by providing amechanism to automate the insertion of compatibleYpsomed 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
Material of components
Inserter	Plastic	Plastic	Same
Spring	Metal	Metal	Same
Design/Energy Source
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
Visualinspection	No crackingNo gross discoloration	Pass
FunctionalTesting	Meets Functional Specifications for:• Activation Torque• Button Activation force• Insertion Force• Reset Torque	Pass
Biological	ISO 10993-5, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity	Pass
Usability	Successful Summative HF Validation	Pass
Life-cycleTesting	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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Image /page/4/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 image of three human profiles facing right, resembling a bird-like shape.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.

Regulation Number and Section

§ 880.6920 Syringe needle introducer.

(a)
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.(b)
Classification. Class II (performance standards).