(233 days)
Not Found
Not Found
No
The description explicitly states the device is "manually operated" and "spring-loaded," with no mention of AI, ML, or any computational processing. The performance studies focus on mechanical and usability aspects.
No.
The device is an insertion aid and does not directly treat a disease or condition; it facilitates the administration of medication by inserting a cannula.
No
The device is described as an "insertion aid" for "automating the insertion of compatible Ypsomed Infusion Sets." Its purpose is to physically assist with the insertion of a cannula, not to diagnose a medical condition or disease.
No
The device description explicitly states it is a "manually operated, spring-loaded insertion aid" made of plastic and powered by a stainless-steel spring, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Orbit Inserter Function: The Orbit Inserter is a mechanical device designed to aid in the physical insertion of a cannula into subcutaneous tissue. It does not analyze any biological samples or provide diagnostic information. Its purpose is purely to facilitate a physical procedure.
The description clearly states its function is to "aid the user with the insertion of the cannula into the subcutaneous tissue" and "automate the insertion of compatible Ypsomed Infusion Sets." This is a delivery mechanism, not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KZH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Tests:
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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1
510(k) Summary for K163400
| Submitted By/
Contact Person: | Stephan Affolter
Head of Quality System & Regulatory Affairs
Ypsomed AG
Brunnmattstrasse 6
CH - 3401 Burgdorf
Switzerland
Tel. 0041-34 424 3382
Fax 0041-34 424 4122
E-mail: stephan.affolter@ypsomed.com |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternative Contact: | Lee Leichter
President
P/L Biomedical
10882 Stonington Avenue
Fort Myers, FL 33913
USA
Tel. (239) 244-1448
Fax. (815) 550-0162
E-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: II
80
KZH
21 CFR 880.6920 |
| 1.5. Purpose of Submission: | To introduce an optional inserter for Orbit Infusion
Sets to the marketplace. |
| 1.7. 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. |
| 1.8. Indication for Use: | 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. |
| 1.9. 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. |
2
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.
3
| Test | Specification | 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 |
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.
4
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.
5
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
6
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.