(88 days)
Not Found
No
The device description and intended use focus on mechanical features (needle, safety mechanism) and standard medical procedures (fluid administration, blood sampling, power injection). There is no mention of AI, ML, or any computational analysis of data.
No
The device is an administration set used to access vascular ports for fluid/drug administration and blood sampling; it does not treat or cure a disease or condition.
No
The device is an infusion set used for administering fluids, drugs, and contrast media, as well as for blood sampling. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical medical device consisting of a needle, administration set, and safety mechanism. There is no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SafeStep® MAX™ Power-Injectable Infusion Set is an intravascular administration set. Its primary function is to access surgically implanted vascular ports for the administration of fluids, drugs, and contrast media, as well as for blood sampling. It is a delivery and access device, not a diagnostic test performed on a sample.
- Lack of Diagnostic Testing: The description focuses on the physical characteristics of the device (needle type, safety mechanism) and its use in delivering substances into the body or withdrawing blood. There is no mention of analyzing a sample to diagnose or monitor a condition.
Therefore, the SafeStep® MAX™ Power-Injectable Infusion Set falls under the category of a medical device used for administration and access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SafeStep® MAX™ Power-Injectable Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The intended use has not changed from that of the predicate devices.
The SafeStep® MAX™ Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports.
The SafeStep® MAX™ Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature.
The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring intravascular administration set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.
The SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles. and 2 ml/s for 22 gauge needles.
The device functions in a similar manner to all the predicate devices. The insertion site is prepared and the device is primed using a 10 ml syringe containing normal saline and inserted into the port septum. Patency is confirmed and the device is dressed per institutional protocol. Removal of the device is accomplished by flushing per institutional protocol, stabilizing the base of the device by securely holding the base down and firmly pulling the textured handle up until you feel a firm stop and the needle is locked into the safety position. Dispose the set into a sharps container.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system, surgically implanted vascular ports
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)
Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.
Performance data gathered in design verification testing demonstrated that the SafeStep® MAX™ Power-Injectable Infusion Set is substantially equivalent to the noted predicate devices.
The SafeStep® MAX™ Power-Injectable Infusion Set met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the SafeStep® MAX™ Power-Injectable Infusion Set is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices: SafeStep® Huber Needle Set(K040527), PowerLoc™ Safety Infusion Set (K060812), Lifeguard Safety Infusion Set (K062414) and Gripper Plus® Power P.A.C. Needle (K070116).
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.
K040527, K021565, K060812, K062414, K070116
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
Page lot 5
Specialized Health Products International, Inc. 510(k) Premarket Notification Submission: SafeStep® MAX™ Power-Injectable Infusion Set
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for SafeStep® MAX™ Power-Injectable Infusion Set
SUBMITTER: Specialized Health Products® International, Inc. 585 West 500 South Bountiful, Utah 84010
ESTABLISHMENT REGISTRATION NUMBER: 1723684
JAN 25 / 00
CONTACT:
Mark Nelson Senior Director, Quality and Regulatory Affairs Telephone: 801-298-3360 Fax: 801-298-1759 Email: marknelson@shpi.com
DATE PREPARED:
January 25, 2008
NAME OF MEDICAL DEVICE:
Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Proprietary Name: SafeStep® MAX™ Power-Injectable Infusion Set
DEVICE CLASSIFICATION:
Classification Panel: General Hospital and Personal Use Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440
PREDICATE DEVICES:
Trade/Device Name: Luther Safety Huber Needle (Re-brunded as "SafeStep" Safety Huber Needle Set") (K040527, K021565) Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Regulation Name: Intravascular Administration Set Classification Panel: General Hospital and Personal Use Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440
Confidential
1
K073056 page 2 of 5
Specialized Health Products International, Inc. 5 10(k) Premarket Notification Submission: SafeStep® MAX™ Power-Injectable Infusion Set
Trade/Device Name: PowerLoc™ Safety Infusion Set (K060812) Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Regulation Name: Intravascular Administration Set Classification Panel: General Hospital and Personal Use Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440
Trade/Device Name: Lifeguard Safety™ Infusion Set (K062414) Regulation Name: Intravascular Administration Set Common/Usual Name: Port Access Infusion Set Regulation Name: Intravascular Administration Set Classification Panel: General Hospital Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440
Trade/Device Name: Gripper Plus® P.A.C. Needle (K070116) Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Regulation Name: Intravascular Administration Set Classification Panel: General Hospital and Personal Use Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440
DEVICE DESCRIPTION:
The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature.
The SafeStep® MAX™ Power-Injectable Infusion Set is a standard non-coring intravascular administration set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.
The SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also
2
indicated for power injection. The maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles. and 2 ml/s for 22 gauge needles.
The device functions in a similar manner to all the predicate devices. The insertion site is prepared and the device is primed using a 10 ml syringe containing normal saline and inserted into the port septum. Patency is confirmed and the device is dressed per institutional protocol. Removal of the device is accomplished by flushing per institutional protocol, stabilizing the base of the device by securely holding the base down and firmly pulling the textured handle up until you feel a firm stop and the needle is locked into the safety position. Dispose the set into a sharps container.
INTENDED USE:
The intended use of the SafeStep® MAX™ Power-Injectable Infusion Set has not changed when compared to the predicate devices. This is the same intended use as the predicates SafeStep Huber Needle Set(K040527), PowerLoc™ Safety Infusion Set (K060812). Lifeguard Safety® Safety Infusion Set (K062414) and Gripper Plus" Power P.A.C. Needle (K070116).
The SafeStep® MAX™ Power-Injectable Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The intended use has not changed from that of the predicate devices.
INDICATIONS FOR USE:
The SafeStep® MAX™ Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports.
The SafeStep® MAX™ Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates.
3
K-73050 page 4 of 5
Specialized Health Products International, Inc. 510(k) Premarket Notification Submission: SafeStep® MAX™ Power-Injectable Infusion Set
Does the new device have the same indication statements? No. The Indications for Use for the infusion set were expanded to include power injection of contrast media into surgically implanted ports that are also indicated for power injection.
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device.
Does the new device have the same technological characteristics, e.g. design, material, etc.? Not in all regards. The SafeStep® MAX™ Power-Injectable Infusion Set has some minor differences from the predicate devices. The basic fundamental scientific technology of the device has not changed.
Could the new characteristics affect safety or effectiveness? Yes, the expanded indication to include power injection of contrast media through a power injection indicated port could affect safety or effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.
The FDA's Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification] Submissions [510(k)], dated April ] 5, 2005.
Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, August 9. 2005.
Sterilization requirements of ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.
Sterilization requirements of ISO 11137: 2006, Sterilization of health care products -Radiation.
Biocompatibility requirements according to of ISO-10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating devices with an indirect blood path with a contact duration of >24 hours to 30 days.
These and other standards were used to determine the appropriate methods for evaluating the modified device's performance.
Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.
Confidential
4
$\frac{1}{2} x + 2$ $\frac{1}{2} x - 5$
Do performance data demonstrate equivalence? Yes. Performance data gathered in design verification testing demonstrated that the SafeStep® MAX™ Power-Injectable Infusion Set is substantially equivalent to the noted predicate devices.
CONCLUSION
The SafeStep® MAX™ Power-Injectable Infusion Set met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the SafeStep® MAX™ Power-Injectable Infusion Set is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices: SafeStep® Huber Needle Set(K040527), PowerLoc™ Safety Infusion Set (K060812), Lifeguard Safety Infusion Set (K062414) and Gripper Plus® Power P.A.C. Needle (K070116).
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Nelson Senior Director, Quality and Regulatory Affairs Specialized Health Products International, Incorporated 585 West 500 South #200 Bountiful, Utah 84010
Re: K073050
Trade/Device Name: SafeStep® MAX™ Power-Injectable Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 25, 2007 Received: October 29, 2007
Dear Mr. Nelson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
6
Page 2 - Mr. Nelson
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); 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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K07-305C
Indications For Use
510(k) Number (if known):
Device Name: SafeStep® MAX™ Power-Injectable Infusion Set
Indications For Use:
The SafeStep® MAX™ Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports.
The SafeStep® MAX™ Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the SafeStep® MAX™ Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cintia V,m
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 73054