(21 days)
Not Found
No
The provided text describes a mechanical safety infusion set and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is used for administration of fluids and drugs or blood sampling, and for safety during needle removal, but it does not treat or cure a disease or condition.
No
Explanation: The device description and intended use clearly state that the LiftLoc® Safety Infusion Set is for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. It is not described as analyzing or interpreting any data to provide a diagnosis.
No
The device description clearly indicates it is a physical medical device consisting of a needle, administration set, and safety mechanism, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. It is a tool for accessing the body for therapeutic or diagnostic purposes, not for performing tests on biological samples in vitro (outside the body).
- Device Description: The description reinforces its function as an intravascular administration set and a non-coring Huber needle for accessing vascular ports.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing biological materials.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to facilitate access to the vascular system for administration or collection, not to perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The LiftLoc® Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.
The integral LiftLock Safety Infusion Set safety mechanism is manually activated during the removal of the LiftLoc® Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.
The LiftLoc® Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
The LiftLoc Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device.
The LiftLoc® Safety Infusion Set may be used in any appropriate patient population.
Product codes
FPA
Device Description
The LiftLoc® Safety Infusion Set is a non-coring Huber needle and administration set with an integral safety needlestick prevention feature. The LiftLoc® Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The LiftLoc® Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.
Following conventional placement of the LiftLoc® Safety Infusion Set's Huber needle into the implanted port and completion of either the prescribed infusion of fluids or blood sample withdrawal, the LiftLoc® Safety Infusion Set may then be removed from the patient.
Conventional clinical practice is used to remove the LiftLoc® Safety Infusion Set from the implanted port. Fingers of the non-dominant hand are placed on top of the LiftLoc Safety Infusion Set's plastic base to stabilize the port. A one-handed (dominant hand) technique is then used to grasp the integral wings and pull upward to remove the Huber needle from the port. When the clinician's hands are positioned correctly over the LiftLoc"s plastic base and the needle is removed, the integral safety mechanism is activated and locks a safety shield covering the needle. An audible click or visual confirmation confirms the lockout of the safety shield over the needle. The LiftLoc Safety Infusion Set, now with a protected needle, is discarded in a sharps container.
All aspects of the device are the same as the predicate device including intended use and the fundamental scientific technology. The presence of lubrication on the needle (medical grade silicone) is the only difference in the modified device compared to the cleared device. Enhanced labeling is also included in this submission.
The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad is also available as an optional accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Surgically implanted vascular ports
Indicated Patient Age Range
Any appropriate patient population
Intended User / Care Setting
Clinician; 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION 3.0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SEP = 8 2004 (21 CFR 807.92) for the LiftLoc® Safety Infusion Set
SUBMITTER: Specialized Health Products®, Inc. 585 West 500 South, Suite 200 Bountiful, Utah 84010
ESTABLISHMENT REGISTRATION NUMBER: 1723684
CONTACT:
Mark Nelson Director, Quality and Regulatory Affairs Telephone: 801-298-3360 Fax: 801-298-1759 Email: marknelson@shpi.com
DATE PREPARED:
August 17, 2004
NAME OF MEDICAL DEVICE:
Classification Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set LiftLoc® Safety Infusion Set Proprietary Name:
DEVICE CLASSIFICATION:
| Classification Panel: | General Hospital and Personal Use |
|---|---|
| Class: | II |
| Procode: | FPA |
| Regulation Number: | 21 CFR 880.5440 |
PREDICATE DEVICE: LiftLock) Safety Infusion Set (K013394), Specialized Health Products®, Inc., Bountiful, UT 84010.
DEVICE DESCRIPTION AND COMPARISON TO CLEARED DEVICE:
The LiftLoc® Safety Infusion Set is a non-coring Huber needle and administration set with an integral safety needlestick prevention feature. The LiftLoc® Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling.
1
The LiftLoc® Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.
Following conventional placement of the LiftLoc® Safety Infusion Set's Huber needle into the implanted port and completion of either the prescribed infusion of fluids or blood sample withdrawal, the LiftLoc® Safety Infusion Set may then be removed from the patient.
Conventional clinical practice is used to remove the LiftLoc® Safety Infusion Set from the implanted port. Fingers of the non-dominant hand are placed on top of the LiftLoc Safety Infusion Set's plastic base to stabilize the port. A one-handed (dominant hand) technique is then used to grasp the integral wings and pull upward to remove the Huber needle from the port. When the clinician's hands are positioned correctly over the LiftLoc"s plastic base and the needle is removed, the integral safety mechanism is activated and locks a safety shield covering the needle. An audible click or visual confirmation confirms the lockout of the safety shield over the needle. The LiftLoc Safety Infusion Set, now with a protected needle, is discarded in a sharps container.
All aspects of the device are the same as the predicate device including intended use and the fundamental scientific technology. The presence of lubrication on the needle (medical grade silicone) is the only difference in the modified device compared to the cleared device. Enhanced labeling is also included in this submission.
The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad is also available as an optional accessory.
INTENDED USE:
The LiftLoc® Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports. The LiftLoc® Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
The LiftLoc® Safety Infusion Set will be marketed as a sterile, non-pyrogenic. single use device. The LiftLoc Safety Infusion Set should be changed per CDC guidelines, Oncology Nursing Society (ONS), Infusion Nurses Society (INS), or per hospital protocol for Huber needle IV administration sets. The LiftLoc® Safety Infusion Set may be used in any appropriate patient population.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is depicted with three lines representing the snakes entwined around the staff.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Mr. Mark Nelson Director, Quality and Regulatory Affairs Specialized Health Products® Incorporated 585 West 500 South #200 Bountiful, Utah 84010
Re: K042234
Trade/Device Name: Modification to: LiftLoc® Safety Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 17, 2004 Received: August 27, 2004
Dear Mr. Nelson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have 10 rowse your and have determined the device is substantially equivalent (for the referenced a o the anclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Intersule confinered pross 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 approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 will), it may of cash of Federal Regulations, Title 21, Parts 800 to 898. In your device tax may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Nelson
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease oc acvisod that 1 Dr. o levice complies with other complies with other requirements Incall that I DAT has mude a december and regulations administered by other Federal agencies. of the Act of ally I oderal states and equirements, including, but not limited to: registration 1 ou inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF Part 807), and ality systems (QS) regulation (21 CFR Part 820); and if requirents us set form in arouv tradiation control provisions (Sections 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) I mis letter will anow Jourse Journal in equivalence of your device to a promatics notified.com - The First 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), If you desire specific at Compliance at (301) 594-4618. 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 may obtain 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/dsma/dsmamain.html
Sincerely yours,
Claire Liu, Ph.D.
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
4
Ko42234
Indications for Use
510(k) Number (if known): ¥042234
Device Name: LiftLoc® Safety Infusion Set
Indications for Use:
- The LiftLoc® Safety Infusion Set device is a safety intravascular administration . set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.
- The integral LiftLock Safety Infusion Set safety mechanism is manually . activated during the removal of the LiftLoc® Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.
- The LiftLoc® Safety Infusion Set is intended for use in the administration of . fluids and drugs, or blood sampling through surgically implanted vascular ports.
- The LiftLoc Safety Infusion Set will be marketed as a sterile, non-pyrogenic, . single use device.
- The LiftLoc® Safety Infusion Set may be used in any appropriate patient ● population.
Prescription Use (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)
Igor Timofeev
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_Kou223y
Page 1 of