(192 days)
The Effectiv The Cap is a device containing 70% Isopropy alcohol. When left in place for 5 to 10 minutes the cap decontaminates the injection port; thereafter the cap provides a physical barrier during intended use.
The Effectiv™ Cap is a cap that holds a sponge soaked with 70% Isopropyl Alcohol (IPA). The cap is provided sterile, Non-DEHP, latex free, single use, and is disposable. The Effectiv Cap is used with standard needleless ports. The Effeciv™ Cap is packaged individually, and sold in cartons.
This document is a 510(k) summary for the Effectiv™ Cap, which is a device intended to decontaminate injection ports. The document outlines the device's technical characteristics and claims substantial equivalence to predicate devices. However, it does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond general cleaning and disinfection.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory classification, intended use, and comparison to predicate devices, but lacks detailed performance study results with acceptance criteria.
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Hospira, Inc. Dr. Rebecca Andersen Global Regulatory Affairs Devices Manager Department-0389 Building H2 275 North Field Dr. Lake Forest, Illinois 60045
March 11, 2022
Re: K080579
Trade/Device Name: Effectiv™ Cap Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP
Dear Dr. Rebecca Andersen:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your original substantial equivalence (SE) determination letter dated September 11, 2008 and the correction letter dated March 12, 2019. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation 880.5440.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, Ob-Gyn, General Hospital and Urology Devices, 240-402-6029, Payal.Patel(@fda.hhs.gov.
Sincerely,
Pror
Payal Patel Assistant Director for General Hospital Devices DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, Ob-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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March 12, 2019
Hospira, Inc. Rebecca Andersen Global Regulatory Affairs Devices Manager 275 North Field Dr. Lake Forest, Illinois 60045
Re: K080579
Trade/Device Name: Effectiv TM Cap Regulatory Class: Unclassified Product Code: OBP Dated: February 20, 2008 Received: March 3, 2008
Dear Rebecca Andersen:
This letter corrects our substantially equivalent letter of September 11, 2018.
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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrb/cfdccs/cfpmn/pmn.cfm.identifies combination.product submissions. 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.
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
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K080579 - Rebecca Andersen
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/uom597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act): 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/6 description: The image contains the text "Geeta K. Pamidimukkala -S". The text is arranged vertically, with "Geeta K." on the top line, "Pamidimukkala" on the second line, and "-S" on the third line. The text appears to be part of a larger document or label.
for 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
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Effectiv™ Cap 510(k) 9/9/08
Section 5: Indications for Use
510(k) Number (unknown at this time)
K0805-79
Effectiv™ Cap Device Name:
Pad, Alcohol, Device Disinfectant
Indications for Use:
The Effectiv The Cap is a device containing 70% Isopropy alcohol. When left in place for 5 to 10 minutes the cap decontaminates the injection port; thereafter the cap provides a physical barrier during intended use.
X Prescription Use (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)
Amman
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 084579
Section 5: Indications Page 1 of 1
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K0805-79
1 of 2
Effectiv™ Cap 510(k) 9/9/08
SEP 1 1 2008
| Section 6: | 510(k) SUMMARY EffectivTM Cap | |||
|---|---|---|---|---|
| 1. Submitted by: | Hospira, Inc.D-389, Bldg. H2275 N. Field DriveLake Forest, IL 60045 | Phone: (224) 212-5270Fax: (224) 212-5401 | ||
| Contact: Rebecca Andersen | ||||
| 2. Date Prepared: | February 28, 2008 | |||
| 3. Name/Classificationof Device: | Pad, Alcohol, Device DisinfectantUnclassifiedLKB | |||
| 4. Trade Name ofProposed Device: | EffectivTM Cap |
5. Predicate Devices:
| Device Name | 510(k) Number |
|---|---|
| Alcohol Swab - Aplicare, Inc. | K833182 |
| Lifeshiled Gravitech Flow Set (with cap) - Hospira | K063239 |
6. Proposed Device Description:
The Effectiv™ Cap is a cap that holds a sponge soaked with 70% Isopropyl Alcohol (IPA). The cap is provided sterile, Non-DEHP, latex free, single use, and is disposable. The Effectiv Cap is used with standard needleless ports. The Effeciv™ Cap is packaged individually, and sold in cartons.
7. Statement of Intended Use:
The Effectiv™ Cap is a device containing 70% Isopropy! alcohol. When left in place for 5 to 10 minutes the cap decontaminates the injection port; thereafter the cap provides a physical barrier during intended use.
8. Summary of Technological Characteristics of New Device Compared to Predicate Devices
The subject and predicate devices are similar in principle of operation, intended use, and labeling.
Section 6: 510(k) Summary Page 1 of 2
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EffectivTM Cap 510(k) 9/9/08
The Alcohol Swab is a non woven pad saturated with 70% Isopropy! alcohol for surface cleaning and disinfecting. The Efectiv™ Cap has a sponge saturated with 70% Isopropyl Alcohol. However, because of its special configuration, a sponge inside the Effectiv™ Cap, its use is restricted to decontamination of injection ports, usually on an IV set, prior to injection.
The claim for substantial equivalence is supported by the information and performance test data provided in the 510(k) submission.
§ 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.