(240 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.
No
The device delivers fluids; it does not treat or cure a medical condition.
No
The device is described as an infusion set for delivering fluids to a patient's vascular system, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components such as air filter, drip chamber, flexible tubing, flow regulator, and infusion needle, indicating it is a physical medical device, not software-only.
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 "delivery of fluids from a container to a patient's vascular system." This describes a device used for administering substances directly into the body, not for examining specimens taken from the body to provide information about a physiological state, health, or disease.
- Device Description: The components listed (air filter, drip chamber, tubing, flow regulator, needle, etc.) are all consistent with a device used for intravenous infusion. There are no components mentioned that would be used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, calibrators, controls, or analytical processes that are characteristic of IVD devices.
In summary, the device described is a medical device used for fluid administration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The devices are indicated for the delivery of fluids from a container to a patient's vascular system.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through the infusion needle under the action of gravity. The proposed devices are comprised of air filter, protective cap of closure-piercing device, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter and an infusion needle attached to a luer adaptor. For the Burette-type Infusion Sets for Single Use, an additional component of burette can used for quantitative infusion. For Disposable Infusion Sets with Precision Filters, a precision membrane is provided for filtration operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO 8536-4:2010 AMD 1 2013, ISO 8536-5:2004, ISO 594-1:1986, ISO 594-2:1998, ISO 9626:1991 AMD 1 2001, ISO 7864: 1993, ISO 10993-7:2008, ASTM F 88/88M-09, ASTM F1140/1140M-13, USP38-NF33 , ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006, ASTM F 756-13.
No clinical study is included in this submission.
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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with a design element above them that resembles a stylized wing or feather.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2017
Beijing Fert Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K161898
Trade/Device Name: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 28, 2017 Received: March 3, 2017
Dear Diana Hong:
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.
1
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 of medical devicerelated 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 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" (21 CFR 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,
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
Indications for Use (Describe)
The devices are indicated for the delivery of fluids from a container to a patient's vascular system.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K161898
-
- Date of Preparation: 03/07/2017
-
- Sponsor Identification
Beijing Fert Technology Co., Ltd.
No. 9, Zhangguozhuang Village, Changxindian Town, Feng Tai District, Beijing, 100072, China
Contact Person: Meng Zhang Position: Quality Director Tel: +86-10-83849578 Fax: +86-10-83805808 Email: zhangmeng@pwmedtech.com
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Burette-type Infusion Sets for Single Use Disposable Infusion Sets with Precision Filters Disposable Infusion Set Common Name: Disposable Infusion Set
Regulatory Information
Classification Name: Set, Administration, Intravascular
Classification: Class II Product Code: FPA Regulation Number: 21CFR 880.5440 Review Panel: General Hospital;
Indications for Use:
The devices are indicated for the delivery of fluids from a container to a patient's vascular system.
Device Description:
The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through the infusion needle under the action of gravity. The proposed devices are comprised of air filter, protective cap of closure-piercing device, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter and an infusion needle attached to a luer adaptor. For the Burette-type Infusion Sets for Single Use, an additional component of burette can used for quantitative infusion. For Disposable Infusion Sets with Precision Filters, a precision membrane is provided for filtration operation.
- Identification of Predicate Device
510(k) Number: K112204 Product Name: KDL Disposable Infusion Set
- Identification of Reference Device
510(k) Number: K972839 Product Name: PROTOS® 100ml Burette Infusion Set/PROTOS® 150ml Burette Infusion
Non-Clinical Test Conclusion 7.
5
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 8536-4:2010 AMD 1 2013 Infusion equipment for medical use, Part 4: Infusion sets for single use, gravity feed
-
ISO 8536-5:2004 Infusion equipment for medical use- Part 5: Burette infusion sets for single use, gravity feed
-
ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 1: General requirements
-
ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings
-
ISO 9626:1991 AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices;
-
ISO 7864: 1993 Sterile hypodermic needles for single use
-
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
-
ASTM F 88/88M-09 Standard test method for seal strength of flexible barrier materials;
-
ASTM F1140/1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages
-
USP38-NF33 Bacterial Endotoxins Tests.
-
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and > delayed-type hypersensitivity
-
ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
-
ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials
-
- Clinical Test Conclusion
-
No clinical study is included in this submission.
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9. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Reference Device |
|---|---|---|---|
| Product Code | FPA | FPA | FPA |
| Regulation Number | 21CFR 880.5440 | 21CFR 880.5440 | 21CFR 880.5440 |
| Indications for Use | The devices are indicated for the delivery of fluids from a container to a patient's vascular system. | KDL Disposable Infusion Set is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein | For the delivery of I.V. solutions by on the order of a physician or other licensed practitioner. |
| Configuration | Protective Cap of Closure-piercing Device | ||
| Air Filter | |||
| Closure-piercing Device | |||
| Flexible Tubing | |||
| Clamp Hook | |||
| Injection Site | |||
| Burette | |||
| Fluid Filter | |||
| Drip Chamber | |||
| Flow Regulator | |||
| Y-shape Injection Site | |||
| Conical Fitting | |||
| Needle Seat | |||
| Wing | Protective Cap of Closure-piercing Device | ||
| Air Filter | |||
| Closure-piercing Device | |||
| Flexible Tubing | |||
| Clamp Hook | |||
| Site Drip | |||
| Chamber Fluid | |||
| Filter Flow | |||
| Regulator | |||
| Injection Site | |||
| Conical Fitting | |||
| Needle Seat | |||
| Wing | |||
| Infusion Needle | |||
| Protective Cap of Infusion Needle | Protective Cap of Closure-piercing Device | ||
| Air Filter | |||
| Closure-piercing Device | |||
| Flexible Tubing | |||
| Clamp Hook | |||
| Injection Site | |||
| Burette | |||
| Fluid Filter | |||
| Drip Chamber | |||
| Flow Regulator | |||
| Y-shape Injection Site | |||
| Conical Fitting | |||
| Needle Seat | |||
| Wing | |||
| Infusion Needle | |||
| Protective Cap of Infusion Needle | Check valve | Infusion Needle | |
| Protective Cap of Infusion Needle | |||
| Sterile | EO sterilized | EO sterilized | EO sterilized |
| 10-6 | 10-6 | 10-6 | |
| Single Use | Single Use | Single Use | Single Use |
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | Conform with ISO 10993 series | |
| standards | Conform with ISO 10993 series | ||
| standards | |||
| Intracutaneous Reactivity | No intracutaneous Reactivity | ||
| Skin Sensitization | No Sensitization | ||
| Acute Systemic Toxicity | No Systemic Toxicity | ||
| Hemolysis | No Hemolysis |
Table 1 Comparison of Technology Characteristics
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- Differences between the subject device indication for use are not identical word. However, the minor differences do . not raise new questions of safety and effectiveness of the reference device K972839 PROTOS® Burette Infusion Set was leveaged for the burette component of the subject device.
- Substantially Equivalent (SE) Conclusion
Based upon the indications for use, technological characteristics, and the results of the subject devices have been demonstrated to be substantially equivalent to the predicate.