(120 days)
K#070189
Not Found
No
The summary describes a mechanical infusion set and does not mention any AI or ML components or functionalities.
No.
The ACCU-CHEK Ultraflex is an infusion set that delivers insulin, but it does not treat or cure a disease itself; it is an accessory to an insulin pump, which is the therapeutic device.
No
This device is an infusion set used for administering insulin, not for diagnosing a condition. Its purpose is to deliver treatment, not to identify or monitor a disease state.
No
The device description clearly states it is an "infusion set" with a "soft cannula" and "adhesive," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of insulin. This is a therapeutic delivery method, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is an infusion set designed to deliver insulin into the subcutaneous tissue. This is a medical device used for treatment, not for analyzing biological samples to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, etc.) or performing diagnostic tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver a substance into the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The ACCU-CHEK® Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
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
health care professional
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)
Functional Testing: In vitro functional testing of the ACCU-CHEK® Ultraflex infusion set was conducted. Biocompatibility testing was performed on the materials used in both devices.
Clinical Studies: Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the ACCU-CHEK® Ultraflex infusion set.
Study Conclusions: Functional Testing: The results of the testing conducted indicate the ACCU-CHEK® Ultraflex infusion set functioned according to specifications and the materials used in the devices are biocompatible. Based upon these results, the product is considered acceptable for human use.
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.
K#070189
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
§ 880.5440 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.
0
R101196
AUG 27 2010
510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence.
Submitter
Submitted by:
Roche Diabetes Care AG
Kirchbergstrasse 190, Postfach
CH-3401 Burgdorf, Switzerland
United States Contact Person:
Scott Thiel
Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana 46250
317-521-3362
scott.thiel@roche.com
Date Prepared: April 27, 2010
Device name
Proprietary name: ACCU-CHEK® Ultraflex infusion set
Common name: subcutaneous infusion set
Classification name: intravascular administration set
Product Code: FPA
Regulation number: 21 CFR 880.5440; Class II
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.
Predicate
device
We claim substantial equivalence to the current legally marketed ACCU-
CHEK® Ultraflex infusion set cleared under K#070189, concurrence received on
February 21, 2007.
Continued on next page
1
510(k) Summary, Continued
| Device description | The ACCU-CHEK® Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus. |
|---|---|
| Intended use | ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. |
Continued on next page:
2
510(k) Summary, Continued
Device Comparisons The modified ACCU-CHEK® Ultraflex infusion set was compared to the current (predicate) ACCU-CHEK® Ultraflex infusion set. The modified ACCU-CHEK® Ultraflex is substantially equivalent to this product by having the same intended use, same storage conditions, same operating conditions, a luer connector, a flexible catheter and needle for insertion into the subcutaneous tissue and separate extension tubing with detachable connector. Both sets have an adhesive patch that secures the headset to the skin. Prior to infusion, both sets require removal of the introducer needle.
Transfer of manufacturing of the infusion set to a new manufacturer, Unomedical A/S, implied minor design modifications to the original model. The purpose of all modifications is to use components and manufacturing processes for the ACCU-CHEK® Ultraflex Infusion set that are already established at Unomedical and used for manufacture of other commercially available infusion sets.
Continued on next page
3
510(k) Summary, Continued
| Summary of
| Studies | Functional Testing: |
|---|---|
| In vitro functional testing of the ACCU-CHEK® Ultraflex infusion set was | |
| conducted. Biocompatibility testing was performed on the materials used in | |
| both devices. | |
| Clinical Studies: | |
| Human clinical studies were not deemed necessary to evaluate the safety or | |
| effectiveness of the ACCU-CHEK® Ultraflex infusion set. | |
| Study | |
| Conclusions | Functional Testing: |
| The results of the testing conducted indicate the ACCU-CHEK® Ultraflex | |
| infusion set functioned according to specifications and the materials used in | |
| the devices are biocompatible. | |
| Based upon these results, the product is considered acceptable for human use. |
4
.
4
Image /page/4/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Scott Thiel Regulatory Affairs Program Manager Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250
AUG 27 2010
Re: K101196
Trade/Device Name: ACCU-CHEK® Ultraflex infusion set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 9, 2010 Received: August 10, 2010
Dear Mr. Thiel:
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.
5
Page 2- Mr. Thiel
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 (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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 vours
Susan Ruane
Anthony D. Watson, B.S., M.S., M.B.A.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known):
Device Name: ACCU-CHEK® Ultraflex infusion set
Indications for Use:
ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soren Ruase
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Infection Control, Dental De
510(k) Númber: