Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of an infusion set, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as delivering fluids and medication, such as insulin, for the subcutaneous treatment of patients, which aligns with the definition of a therapeutic device.

Diagnostic

No

This device is designed for the subcutaneous delivery of fluids and medication, not for diagnosing conditions or diseases. Its purpose is to administer treatment.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like tubing, luer lock connections, adhesive bases, and catheters, indicating it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump." This describes a device used to administer substances into the body, not to test samples from the body.
Device Description: The description details tubing, connections, a catheter, and an adhesive base for delivering fluids subcutaneously. This aligns with a drug delivery device, not a diagnostic test.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of substances.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

FPA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Ypsomed 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 results:

Material strength of steel cannula: Pass
Activated pressure leak: Pass
Penetration force: Pass
Needle retention: Pass
Catheter retention: Pass
Bond strength of tubing/fittings: Pass
Bond strength of tape/base: Pass
Engagement force tubing cap/base: Pass
Disengagement force tubing cap/base: Pass
Occlusion test: Pass
Tape adhesion: Pass

Biocompatibility tests performed 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

Key Metrics

Not Found

Predicate Device(s)

K130468

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY for K150921

| Submitted By/ Contact Person: | Stephan Affolter
Head of Quality System & Regulatory Affairs
Ypsomed AG
Brunnmattstrasse 6
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: | 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: II
Panel: 80
Product Code: FPA
Regulation: 21 CFR 880.5440 |

1. Predicate Device: K130468 Orbit Infusion Set
1. 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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1. 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.
1. Intended Use:
  The intended use of the subject devices remains the same as the predicate devices (K130468):

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

1. 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.

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 0.44mm
OD 0.76mm

Introducer Needle:
ID 0.20 mm
OD 0.41 (27G) | Stainless steel cannula (31G):
ID 0.11 mm
OD 0.25 mm

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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 material
for the cannula,
but the same
stainless steel as
for the introducer
needle of the
subject device
UV Glue bond	Adhesive	Adhesive	Same type of
adhesive (acrylic
urethane 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 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

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| 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 |

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.