(372 days)
Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.
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.
This document describes the 510(k) submission for the Orbit®micro Infusion Set. This is a medical device and not an AI/ML powered device, therefore the typical acceptance criteria and study data for AI/ML devices, such as those related to accuracy, sensitivity, specificity, MRMC studies, or ground truth establishment based on expert consensus/pathology, are not applicable here.
The provided text details the performance testing conducted to demonstrate the substantial equivalence of the Orbit®micro Infusion Set to a predicate device (K130468). The acceptance criteria are essentially the specifications that the device must meet, and the "results" column indicates whether these criteria were passed.
Here's the information as requested, adapted to the context of a medical device rather than an AI system:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Material strength of steel cannula | Material strength per ISO 9626 | Pass |
| Activated pressure leak | No leak when subjected to pumping pressures up to 20psi under normal delivery conditions and occluded fluid path conditions | Pass |
| Penetration force | Needle and catheter shall penetrate a 0.025 inch thick membrane with a speed of 50mm/min. and a force of less than 0.8N | Pass |
| Needle retention | No separation of the needle from the cap when subjected to a minimum force of 10N (ISO 10555-1, Annex B) | Pass |
| Catheter retention | No separation of the catheter from the base when subjected to a minimum force of 3N (ISO 8536-8) | Pass |
| Bond strength of tubing/fittings | No separation of the tubing assembly when subjected to a static tensile force of 15N for 15 sec. | Pass |
| Bond strength of tape/base | No separation of the tape from the base when subjected to a minimum force of 18N | Pass |
| Engagement force tubing cap/base | The cap locks on the base with a force less than 13N | Pass |
| Disengagement force tubing cap/base | The force to remove the tubing cap from the base is more than 13N | Pass |
| Occlusion test | No occlusion of the device when tested with a water flow at a hydrostatic pressure of 0.1 bar | Pass |
| Tape adhesion | Removal of adhesive from a stainless steel plate with a 90 degree peel force of minimum 2.5N (0.56lbs) | Pass |
| Biocompatibility Tests (ISO 10993-1) | Acceptable results for: Cytotoxicity ISO MEM Elution Assay; Hemolysis ASTM Assay Extract Method; Acute Systemic Injection; Guinea Pig Maximization Sensitization; Intracutaneous reactivity study; Bacterial Endotoxin. (Specific quantifiable acceptance criteria for each sub-test are not provided in the document but are implied by "acceptable results" per the standard.) | Completed with acceptable results for all listed tests. |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each performance test. The tests are physical/mechanical property tests of the device components and entire system, not tests on biological or imaging data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical sense for an AI/ML context. The tests were conducted by Ypsomed AG, a Swiss company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these types of device performance tests is established by adherence to international standards (e.g., ISO) and engineering specifications, often measured by calibrated equipment, rather than requiring expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML study involving human readers or interpretation.
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
Not applicable. This is a medical device, not an AI system. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. The performance tests ("standalone") refer to the device's inherent mechanical and material properties.
7. The type of ground truth used
The "ground truth" for the device's performance is based on established engineering principles, international standards (like ISO 9626, ISO 10555-1, ISO 8536-8, ISO 10993-1), and the predefined specifications set by the manufacturer to ensure the device performs as intended and is safe. This isn't "expert consensus," "pathology," or "outcomes data" in the context of diagnostic accuracy, but rather compliance with physical and biological requirements through standardized testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem depicting a stylized human figure with three faces in profile, layered on top of each other.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 AffolterHead of Quality System & Regulatory AffairsYpsomed AGBrunnmattstrasse 63401 BurgdorfSwitzerlandTel. 0041-34 424 3382Fax 0041-34 424 4122E-mail: stephan.affolter@ypsomed.com |
|---|---|
| Alternative Contact: | Lee LeichterPresidentP/L Biomedical 10882 Stonington AvenueFort Myers, FL 33913USATel. (239) 244-1448Fax. (815) 550-0162E-mail: leichter@plbiomedical.com |
| 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: IIPanel: 80Product Code: FPARegulation: 21 CFR 880.5440 |
-
- Predicate Device: K130468 Orbit Infusion Set
-
- 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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-
- 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.
- Device Description
-
- Intended Use:
The intended use of the subject devices remains the same as the predicate devices (K130468):
- Intended Use:
Orbit®micro Infusion Sets are intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.
-
- 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.
- Technological Characteristics:
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:ID 0.44mmOD 0.76mmIntroducer Needle:ID 0.20 mmOD 0.41 (27G) | Stainless steel cannula (31G):ID 0.11 mmOD 0.25 mmStainless steel cannula (27G):ID 0.24 mmOD 0.41 mm | Differentdimensions |
| Cannula Length | 6mm, 9mm | 5.5mm, 8mm, 8.5mm | Differentdimensions |
| 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 layerPE Polyethylene (LDPE) - innerlayerco-extruded | PVC - outer layerLDPE - 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(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 materialfor the cannula,but the samestainless steel asfor the introducerneedle of thesubject device |
| UV Glue bond | Adhesive | Adhesive | Same type ofadhesive (acrylicurethane adhesive,UV-cured),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 strengthof steel cannula | Material strength per ISO 9626 | Pass |
| Activated pressure leak | No leak when subjected to pumping pressures up to 20psiunder normal delivery conditions and occluded fluid pathconditions | Pass |
| Penetration force | Needle and catheter shall penetrate a 0.025 inch thickmembrane with a speed of 50mm/min. and a force of lessthan 0.8N | Pass |
| Needle retention | No separation of the needle from the cap when subjected toa minimum force of 10N (ISO 10555- 1, Annex B) | Pass |
| Catheter retention | No separation of the catheter from the base whensubjected to a minimum force of 3N (ISO 8536-8) | Pass |
| Bond strength oftubing/fittings | No separation of the tubing assembly when subjected to astatic tensile force of 15N for 15 sec. | Pass |
| Bond strength oftape/base | No separation of the tape from the base when subjected toa minimum force of 18N | Pass |
| Engagement forcetubing cap/base | The cap locks on the base with a force less than 13N | Pass |
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| Disengagement forcetubing cap/base | The force to remove the tubing cap from the base is morethan 13N | Pass |
|---|---|---|
| Occlusion test | No occlusion of the device when tested with a water flowat a hydrostatic pressure of 0.1 bar | Pass |
| Tape adhesion | Removal of adhesive from a stainless steel plate with a 90degree 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.
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.