(101 days)
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Extension Sets with Secure Lock are intended for use as gravity sets. Hospira infusion sets are disposable devices for single patient use.
The provided text is related to a 510(k) premarket notification for a medical device called "Hospira Extension Set." This is an IV administration set. The document confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the specific information requested in the prompt concerning acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a software algorithm or AI device.
The document discusses:
- Device Name: Hospira Extension Set
- Regulation Number: 21 CFR 880.5440
- Regulation Name: IV Administration Sets
- Regulatory Class: II
- Product Code: FPA
- Indications for Use: "Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system."
- Predicate Devices: LifeShield Vision Infusion Sets - K113683, Hospira Infusion Blood Sets - K101677, LifeShield Latex Free Microbore Set - K052722
- Reason for 510(k) submission: Modification to Secure Lock Male Luer
- Summary of non-clinical tests: Stated that "All materials of construction for Hospira Extension Sets meet the applicable material test requirements for ISO 10993."
- Summary of Performance Testing: "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable. The product Sterility Assurance Level is $10^{-6}$."
The information requested in the prompt (acceptance criteria table, sample sizes for test/training, data provenance, number/qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, etc.) is typically associated with studies for AI/ML-enabled devices involving diagnostic or predictive tasks. The Hospira Extension Set is a physical medical device (IV administration set), and its 510(k) submission primarily relies on demonstrating substantial equivalence to predicates through material compatibility, physical performance testing, and sterility, rather than clinical studies with human readers or AI algorithms as described in your request.
Therefore, I cannot extract the requested information from the provided document as it is not relevant to this type of device and submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Hospira, Inc Mr. David Blonski Director Regulatory Affairs 375 Field Drive Lake Forest, Illinois 60045
Re: K142433 Trade/Device Name: Regulation Number: 21 CFR 880.5440 Regulation Name: IV Administration Sets Regulatory Class: II Product Code: FPA Dated: August 28, 2015 Received: August 29, 2015
Dear Mr. Blonski:
This letter corrects our substantially equivalent letter of December 8, 2014.
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.
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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 (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" (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 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 yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K142433
Device Name: Hospira Extension Set
Indications for Use: Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
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Section 5 510(k) Summary K142433
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 for Hospira Extension Sets.
| Submitter Information | |
|---|---|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H2275 North Field DriveLake Forest, IL. 60046 |
| Phone number | (224) 212-5010 |
| Mobile number | (224) 515-6807 |
| Fax number | (224) 212-5401 |
| Establishment Registration Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | David Blonski, Director Regulatory Affairs |
| Date prepared | August 28, 2014 |
| Name of device | |
| Trade or proprietary name | Extension Sets |
| Common or usual name | I.V Administration Sets |
| Classification name | Intravascular Administration Set, 21 CFR 880.5440, Class II |
| Product Code(s) | FPA |
| Legally marketed device(s) to which equivalence is claimed | LifeShield Vision Infusion Sets - K113683Hospira Infusion Blood Sets - K101677LifeShield Latex Free Microbore Set - K052722 |
| Reason for 510(k) submission | The changes addressed in this submission include:• Modification to Secure Lock Male Luer |
| Device description | The Hospira Extension Sets with Secure Lock are intended for use as gravity sets.Hospira infusion sets are disposable devices for single patient use. |
| Intended Use of Device | Hospira Extension set is intended for the delivery of fluids from a container to a patient's vascular system. |
CONFIDENTIAL
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Image /page/4/Picture/1 description: The image shows the word "Hospira" in a serif font, with the "H" capitalized and the rest of the letters in lowercase. Above the word is a stylized graphic consisting of four curved lines that converge at the top, resembling a stylized wing or abstract design. The image is in black and white.
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Predicate | Proposed Device |
| Indications for Use | Hospira Extension Set is intended forthe delivery of fluids from a containerto a patient's vascular system. | Same |
| Materials of Contruction | The materials of construction for the proposed device are exactly the same as thematerials for the predicate product | Same |
| Summary of non-clinical tests fordetermination of substantialequivalence | All materials of constrction for HospiraExtension Sets meet the applicablematerial test requirements for ISO10993 | Same |
| Summary of Performance Testing | Performance testing was conducted toensure the device performs as intendedin accordance with applicablestandards. All testing is acceptable.The product Sterility Assurance Leve is$10^{-6}$ . | Same |
Conclusion
Hospira Extension Sets meet the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the LifeShield Vision Infusion Sets cleared under K113683, Hospira Infusion Blood Sets cleared under K 101677 and LifeShield Latex Free Microbore Set cleared under K052722.
§ 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.