(265 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes
This device is used to administer fluids or withdraw blood, which are therapeutic actions or aid in patient care by facilitating diagnosis or treatment.
No
The device is an infusion set used to administer fluids or withdraw blood, not to diagnose a condition.
No
The device description clearly details physical components like needles, tubing, clamps, and packaging, and the performance studies focus on physical properties and testing. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer fluids or to withdraw blood through the implanted vascular port." This describes a device used for direct patient care and treatment (infusion and blood collection), not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical components and function of a needle and tubing set for accessing a vascular port. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (e.g., blood, urine, tissue)
- Diagnostic claims or interpretation of results
- Use in a laboratory setting
The device is clearly intended for clinical use in accessing a patient's vascular system for therapeutic or sample collection purposes, which falls under the category of a medical device used for treatment or procedural support, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient's surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.
Product codes
FPA
Device Description
The Infusion Safety Products, Inc. ISP Safety Huber Needle Infusion Set is a non-coring safety IV administration set used to access a patient's surgically implanted vascular port. The Safety Huber Needle Infusion Set is constructed with a 90°, non-coring Huber needle that is available in 19ga, 20ga and 22ga and in ½", ¾", 1″ and 1½" lengths. It is offered in the following model numbers:
| 19 ga needle | 20 ga needle | 22 ga needle |
|---|---|---|
| ISP195 | ISP205 | ISP225 |
| ISP195Y | ISP205Y | ISP225Y |
| ISP1975 | ISP2075 | ISP2275 |
| ISP1975Y | ISP2075Y | ISP2275Y |
| ISP191 | ISP201 | ISP221 |
| ISP191Y | ISP201Y | ISP221Y |
| ISP1915 | ISP2015 | ISP2215 |
| ISP1915Y | ISP2015Y | ISP2215Y |
The device is lipid resistant and contains non-latex containing products. The PVC Tubing is non-DEHP, with a flow rate of approximately 5cc per sec. max / CT rated to 300 psi. The Safety Huber Needle Infusion Set is packaged in a semi-rigid form fill and seal package with a 1059B Tyvek® lid. The sets are sterilized using a validated ethylene oxide method.
The ISP Safety Huber Needle Infusion Set is intended to administer fluids or withdraw blood through the implanted vascular port (not included with the ISP Safety Huber Needle Infusion Set device is offered in the following configurations, each with various needle gauges and needle lengths:- 1. Huber needle in a needle holder in a safety wing, a 7.50" length of PVC Tubing, ratchet clamp, female luer lock and vented-protector cap. Approximate Priming Volume: 0.25cc.
- 2. Huber needle in a needle holder in a safety wing, a 4.12″ length of PVC tubing with a ratchet clamp attached to a Y port with a non-vented cap, a second 4.12″ length of PVC off the Y port with a ratchet clamp, a female luer lock and non-vented protector cap. Approximate Priming Volume: 0.35cc.
The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needles by encapsulating the needle within the wing to help prevent needle stick injuries when using the device for vascular port access. The safety mechanism is engaged when the needle is removed from the access port. As the set is removed from the patient, the wing encapsulates the needle, making an audible click when secure, to prevent needle sticks to the clinician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgically implanted vascular port
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 performance tests were conducted to demonstrate safety and effectiveness and substantial equivalence to the predicate device.
- Needle Insertion/Removal Force: Comparison testing showed the same forces are required for both the subject and predicate device. Passed.
- Occlusion Testing: Neither the subject nor the predicate device showed occlusions at 45 psi. Passed.
- Leak Testing: Neither the subject nor the predicate device showed occlusions at 100 psi; the ISP Safety Huber Needle Infusion Set also had no leaks when tested at 330 psi. Passed.
- Bonding Forces: All devices tested withstood 10 lbs. of force. Passed.
- Flow Rate: Both devices achieved a rate of 45 ml/min at 150 mmHg. Passed.
- Simulated clinical study: Puncture resistance forces of the safety wings were the same for the subject and predicate devices; subject device required less force to lock the safety wings into place than the predicate; both subject and predicate safety wing were successfully activated 200 times without failure. Passed all tests.
Additional device testing included: - Sharps injury protection testing (ISO 23908): Activation force of the safety wing met acceptance criterion of ≤ 2.5 lbs; Force to remove needle from port and continue full activation met acceptance criterion of ≤ 5 lbs at each of three (3) pull speeds; Force to over-ride Safety Wing feature met the requirement to withstand minimum of 8 lbs force. Passed.
- Simulated Use testing: The ISP Safety Huber Needle Infusion Set was demonstrated as safe and effective in preventing potential needle-stick injuries, and that the device may be used with one hand. Passed.
- Biocompatibility: The subject device passed acceptance criteria for cytotoxicity (ISO 10993-5); irritation/intracutaneous reactivity, sensitization (ISO 10993-10); systemic toxicity and subchronic toxicity (ISO 10993-11); hemocompatibility (ISO 10993-4) including hemolysis, partial thromboplastin, complement activation assay (c3a), and complement activation assay (sc5b-9). Passed all tests.
- Sterilization by ethylene oxide (ISO 11135) and ethylene oxide residual testing (AAMI/ANSI/ISO 10993-7): Obtained SAL of 10-6; EO residuals met the release acceptance criteria of
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 14, 2017
Infusion Safety Products, Inc. % Audrey Swearingen Director, Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Rd., Bldg. 1, Suite 300 Austin, Texas 78746
Re: K170881
Trade/Device Name: ISP Safety Huber Needle Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: November 17, 2017 Received: November 21, 2017
Dear Audrey Swearingen:
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 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" (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) K170881
Device Name ISP Safety Huber Needle Infusion Set
Indications for Use (Describe)
The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient's surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
ISP Safety Huber Needle Infusion Set
K170881
1. Submission Sponsor
Infusion Safety Products, Inc. 26 Victoria Court
Keene, New Hampshire 03431
USA
Contact: Alan P. Reid
Title: President
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Audrey Swearingen, RAC Title: Director, Regulatory Affairs
3. Date Prepared
December 7, 2017
4. Device Identification
| Trade/Proprietary Name: | ISP Safety Huber Needle Infusion Set |
|---|---|
| Common/Usual Name: | Huber Needle Administration Set |
| Classification Name: | Hypodermic Single Lumen Needle |
| Regulation Number: | 880.5570 |
| Product Code: | PTI |
| Device Class: | Class II |
| Classification Panel: | General Hospital Devices |
4
5. Legally Marketed Predicate Device(s)
K993848 - Millennium Huber Plus Safety Infusion Set, Millennium Medical Distribution, Inc.
6. Indication for Use Statement
The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient's surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set contains a sharps injury prevention feature that facilitates safe removal of the needle by encapsulating the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.
7. Device Description
The Infusion Safety Products, Inc. ISP Safety Huber Needle Infusion Set is a non-coring safety IV administration set used to access a patient's surgically implanted vascular port. The Safety Huber Needle Infusion Set is constructed with a 90°, non-coring Huber needle that is available in 19ga, 20ga and 22ga and in ½", ¾", 1″ and 1½" lengths. It is offered in the following model numbers:
| 19 ga needle | 20 ga needle | 22 ga needle |
|---|---|---|
| ISP195 | ISP205 | ISP225 |
| ISP195Y | ISP205Y | ISP225Y |
| ISP1975 | ISP2075 | ISP2275 |
| ISP1975Y | ISP2075Y | ISP2275Y |
| ISP191 | ISP201 | ISP221 |
| ISP191Y | ISP201Y | ISP221Y |
| ISP1915 | ISP2015 | ISP2215 |
| ISP1915Y | ISP2015Y | ISP2215Y |
The device is lipid resistant and contains non-latex containing products. The PVC Tubing is non-DEHP, with a flow rate of approximately 5cc per sec. max / CT rated to 300 psi. The Safety Huber Needle Infusion Set is packaged in a semi-rigid form fill and seal package with a 1059B Tyvek® lid. The sets are sterilized using a validated ethylene oxide method.
The ISP Safety Huber Needle Infusion Set is intended to administer fluids or withdraw blood through the implanted vascular port (not included with the ISP Safety Huber Needle Infusion Set device is offered in the following configurations, each with various needle gauges and needle lengths:
-
- Huber needle in a needle holder in a safety wing, a 7.50" length of PVC Tubing, ratchet clamp, female luer lock and vented-protector cap. Approximate Priming Volume: 0.25cc.
-
- Huber needle in a needle holder in a safety wing, a 4.12″ length of PVC tubing with a ratchet clamp attached to a Y port with a non-vented cap, a second 4.12″ length of PVC off the Y port with a
5
ratchet clamp, a female luer lock and non-vented protector cap. Approximate Priming Volume: 0.35cc.
The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needles by encapsulating the needle within the wing to help prevent needle stick injuries when using the device for vascular port access. The safety mechanism is engaged when the needle is removed from the access port. As the set is removed from the patient, the wing encapsulates the needle, making an audible click when secure, to prevent needle sticks to the clinician.
8. Substantial Equivalence Discussion
The following table compares the ISP Safety Huber Needle Infusion Set to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities and differences to the predicate device.
| Manufacturer | Multi-Med, Inc. for | Millennium Medical | Device Comparison |
|---|---|---|---|
| Infusion Safety Products, | Distribution, Inc. | ||
| Inc. | |||
| Trade Name | ISP Safety Huber Needle | Millennium Huber Plus | |
| Infusion Set | Safety Needle Infusion Set | ||
| (K993848) | |||
| Product Code | PTI | FPA | Different. |
| Regulation | 880.5570 | 880.5440 | Different |
| Number | |||
| Regulation Name | Hypodermic Single Lumen | Intravascular administration | Different; both are Huber |
| Needle | set | needles with tubing for | |
| intravascular | |||
| administration | |||
| Indications for Use | The ISP Safety Huber Needle | The Millennium Huber Plus | Same |
| Infusion Set is a safety IV | Safety Infusion Set is a | ||
| administration set with a | safety IV administration set | ||
| non-coring, ninety degree, | with a non-coring, ninety- | ||
| right angled Huber needle, | degree, right-angle Huber | ||
| used to access a patient's | needle, used to access | ||
| surgically implanted | surgically implanted | ||
| vascular port. The ISP | vascular ports. The Huber | ||
| Safety Huber Needle | needle is used to administer | ||
| Infusion Set is intended to | fluids or to withdraw blood. | ||
| administer fluids or to | The Huber Plus system | ||
| withdraw blood through the | facilitates safe removal of | ||
| Manufacturer | Multi-Med, Inc. for | Millennium Medical | Device Comparison |
| Infusion Safety Products, | Distribution, Inc. | ||
| Inc. | |||
| Trade Name | ISP Safety Huber Needle | Millennium Huber Plus | |
| Infusion Set | Safety Needle Infusion Set | ||
| (K993848) | |||
| implanted vascular | the needle by encapsulating | ||
| port. The ISP Safety Huber | the needle within the | ||
| Needle Infusion Set | attachment wings to help | ||
| contains a sharps injury | prevent needlestick injuries | ||
| prevention feature that | when using the device for | ||
| facilitates safe removal of | vascular port access. | ||
| the needle by encapsulating | |||
| the needle within the wing | |||
| to help prevent needlestick | |||
| injuries when using the | |||
| device for vascular port | |||
| access. | |||
| Mechanism of | Standard Huber needle | Standard Huber needle | Same |
| Action | infusion set operation. | infusion set operation. | |
| When the needle is | When the needle is | ||
| removed from the patient a | removed from the patient a | ||
| portion of the wing | portion of the wing | ||
| automatically surrounds the | automatically surrounds the | ||
| needle to prevent | needle to prevent | ||
| accidental needle-stick | accidental needle-stick | ||
| injuries. | injuries. | ||
| Needle Gauges | 19, 20, 22 | 19, 20, 22 | Same |
| Needle Lengths | ½, ¾, 1, 1½ inches | ½, ¾, 1, 1½ inches | Same |
| Materials | Medical grade 304 stainless | Medical grade 304 stainless | Same for most |
| steel, | steel, | components. | |
| K-Resin SBC, | Medical grade | Biocompatibility testing | |
| Medical grade PVC, | polypropylene, | demonstrates | |
| Medical grade | Cryolite G20, | equivalence in that no | |
| polypropylene, | Medical grade PVC, | different questions of | |
| Tubing: Medical grade non- | Tubing: Medical grade non- | safety are raised. | |
| DEHP PVC | DEHP PVC | ||
| Tubing Lengths | 7.5" (without Y-port); | 7" (without Y-port); | Same; minor variations do |
| 8.24" (with Y-port) | 8.5" (with Y-port) | not raise new questions | |
| of safety or effectiveness | |||
| Sterile, Single-Use | Yes | Yes | Same |
| Manufacturer | Multi-Med, Inc. for | ||
| Infusion Safety Products, Inc. | Millennium Medical | ||
| Distribution, Inc. | Device Comparison | ||
| Trade Name | ISP Safety Huber Needle | ||
| Infusion Set | Millennium Huber Plus | ||
| Safety Needle Infusion Set | |||
| (K993848) | |||
| Performance: | Same or Similar; small | ||
| variations do not raise | |||
| different questions of | |||
| safety or effectiveness | |||
| Force to lock | |||
| safety wings | 160 – 180g (Chatilon gauge) | 240 – 260g (Chatilon gauge) | |
| Force to Insert | |||
| Needle | 2.20 – 2.75 lbs | 2.20 – 2.65 lbs | |
| Force to Remove | |||
| Needle | 2.20 – 2.50 lbs | 2.20 – 2.50 lbs | |
| Puncture | |||
| resistance of wings | 5.9 – 6.1 lbs | 5.5 – 6.0 lbs | |
| Bond separation | |||
| forces | All bonds withstood 10 lbs force | All bonds withstood 10 lbs force | |
| Occlusions at 45 psi | None | None | |
| Leaks at 100 psi | None | None | |
| Tested to ISO 23908 | Yes, passed | Not known | N/A |
Table 5A – Comparison of Characteristics
6
7
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of ISP Safety Huber Needle Infusion Set and in showing substantial equivalence to the predicate device, Infusion Safety Products, Inc. completed a number of non-clinical performance tests. The ISP Safety Huber Needle Infusion Set passed all the testing in accordance with internal requirements, national standards, and international standards for overall design, sterilization, biocompatibility, and performance, with test results confirming that the design output meets the design inputs and specifications for the device.
Performance comparison tests supporting substantial equivalence to the predicate device are listed below:
- . Needle Insertion/Removal Force – Comparison testing showed the same forces are required for both the subject and predicate device. Passed.
- . Occlusion Testing – Neither the subject nor the predicate device showed occlusions at 45 psi. Passed.
- . Leak Testing - Neither the subject nor the predicate device showed occlusions at 100 psi; the ISP Safety Huber Needle Infusion Set also had no leaks when tested at 330 psi. Passed.
- . Bonding Forces - All devices tested withstood 10 lbs. of force. Passed.
- Flow Rate – Both devices achieved a rate of 45 ml/min at 150 mmHg. Passed.
8
-
Simulated clinical study - Puncture resistance forces of the safety wings were the same for the subject and predicate devices; subject device required less force to lock the safety wings into place than the predicate; both subject and predicate safety wing were successfully activated 200 times without failure. Passed all tests.
Additional device testing included: -
Sharps injury protection testing (ISO 23908) Activation force of the safety wing met acceptance . criterion of ≤ 2.5 lbs; Force to remove needle from port and continue full activation met acceptance criterion of ≤ 5 lbs at each of three (3) pull speeds; Force to over-ride Safety Wing feature met the requirement to withstand minimum of 8 lbs force. Passed.
-
. Simulated Use testing - The ISP Safety Huber Needle Infusion Set was demonstrated as safe and effective in preventing potential needle-stick injuries, and that the device may be used with one hand. Passed.
-
. Biocompatibility – The subject device passed acceptance criteria for cytotoxicity (ISO 10993-5); irritation/intracutaneous reactivity, sensitization (ISO 10993-10); systemic toxicity and subchronic toxicity (ISO 10993-11); hemocompatibility (ISO 10993-4) including hemolysis, partial thromboplastin, complement activation assay (c3a), and complement activation assay (sc5b-9). Passed all tests.
-
Sterilization by ethylene oxide (ISO 11135) and ethylene oxide residual testing (AAMI/ANSI/ISO 10993-7) – Obtained SAL of 10 °; EO residuals met the release acceptance criteria of