(266 days)
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.
The 3M™ Curos Jet™ Disinfecting Cap is a single use, sterile cap that contains 70% Isopropy Alcohol and is intended to disinfect and protect needleless connectors. The Curos Jet™ Disinfecting Cap is translucent green in color. The device consists of a molded high-density polyethylene (HDPE) cap designed to fit onto female threads of a needleless connector, containing a HDPE plunger within. This plunger, when the cap is screwed onto a connector, travels towards a reservoir of 70% Isopropyl Alcohol, releasing it onto the needleless connector for disinfection. The Curos Jet™ Disinfecting Cap is offered in one size only, however it is packaged in "single" (1-cap) and "strip" (5-cap) configurations on a foil seal.
The provided document is a 510(k) summary for the 3M™ Curos Jet™ Disinfecting Cap. It describes the device, its intended use, comparison to predicate/reference devices, and non-clinical performance testing. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, which is implied by several of your questions (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)").
This document is for a medical device, specifically a disinfecting cap, not an AI/ML software as a medical device (SaMD). Therefore, many of your questions related to AI/ML device testing (such as ground truth establishment for training/test sets, expert consensus, MRMC studies, and human-in-the-loop performance) are not applicable to the information provided in this regulatory submission.
The acceptance criteria and performance data relate to the disinfection efficacy of the physical cap.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for disinfection efficacy is defined as "≥ 4 Log count reduction" against specific microorganisms.
| Microorganism | Acceptance Criteria (Log Reduction) | Reported Mean Log Reduction (1-Minute) | Reported Mean Log Reduction (7-Day) |
|---|---|---|---|
| Candida albicans | ≥ 4 | 5.25 | 5.25 |
| Candida glabrata | ≥ 4 | 4.53 | 5.46 |
| Escherichia coli | ≥ 4 | 4.57 | 4.94 |
| Pseudomonas aeruginosa | ≥ 4 | 5.03 | 5.55 |
| Staphylococcus aureus | ≥ 4 | 5.36 | 5.15 |
| Staphylococcus epidermis | ≥ 4 | 4.70 | 5.22 |
Note: The document also mentions other acceptance criteria for "foil seal peel strength, cap retention force to needleless connectors, as well as cap compatibility with needleless connectors via pressure/vacuum leak testing," but the specific numerical acceptance values for these are not provided in this summary. The summary states that "All testing was completed in accordance with approved company protocols and was completed to demonstrate that the Subject Device seals and acts as a cover for needleless connectors."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of caps or tests) used for the microbiology efficacy testing. It refers to "test results" and "mean Log reduction" which suggests multiple trials were conducted.
- Data Provenance: The efficacy testing was conducted in vitro. The document does not specify the country of origin for the data collection, but given it's part of a US FDA submission by a US company (3M Company, St. Paul, Minnesota), it's highly likely the tests were conducted in the US or in labs compliant with US regulatory standards for medical devices. The testing is described as "non-clinical performance test data," implying it's laboratory-based, not patient-based data. It is retrospective in the sense that the testing was completed and results summarized for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This question is not applicable. The "ground truth" for this device's performance is objective laboratory measurement of microbial reduction, not subjective expert interpretation of, for instance, medical images.
4. Adjudication Method for the Test Set
- This question is not applicable. There is no human interpretation or adjudication involved in the microbial log reduction testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This question is not applicable. This is a physical medical device, not an AI/ML diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is a physical medical device, not an algorithm. The "performance" is the inherent disinfectant action of the cap.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the primary efficacy claim (disinfection) is objective laboratory measurement of microbial reduction (colony-forming unit counts before and after disinfection), which is a direct measure of the device's intended biological effect on microorganisms.
- For other performance aspects (foil seal peel strength, cap retention force, compatibility, sterility, biocompatibility), the ground truth is established through physical, chemical, and biological testing according to established international standards (e.g., ISO, FDA guidance).
8. The Sample Size for the Training Set
- This question is not applicable. This device does not involve an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- This question is not applicable. This device does not involve an AI/ML algorithm that requires a "training set."
In summary, the provided document details the non-clinical performance testing of a physical medical device (disinfecting cap) based on a defined microbiological acceptance criterion. It does not involve AI/ML technology or human reader studies.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
3M Company Dianne Gibbs Regulatory Affairs Manager 2510 Conway Ave. St. Paul, Minnesota 55144-1000
March 11, 2022
Re: K200299
Trade/Device Name: Curos Jet Disinfecting Cap Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP
Dear Dianne Gibbs:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 29, 2020. 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,
Signature
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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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is in blue and consists of the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. To the left of the FDA logo is the Department of Health & Human Services logo, which is a stylized image of a human figure.
October 29, 2020
3M Company Dianne Gibbs Regulatory Affairs Manager 2510 Conway Ave., Bldg. 275-5NW-06 St. Paul. Minnesota 55144-1000
Re: K200299
Trade/Device Name: Curos Jet Disinfecting Cap Regulatory Class: Unclassified Product Code: QBP Dated: September 28, 2020 Received: September 29, 2020
Dear Dianne Gibbs:
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. 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/cdrh/cfdocs/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 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
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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 (Sections 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sapana Patel -S
Payal Patel for Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Expiration Date
See PRA State
K200299
Device Name
Curos Jet™ Disinfecting Cap for Needleless Connectors - Single (CFJ1-270); Curos Jet™ Disinfecting Cap for Needleless Connectors - Strip (CFJ5-250)
Indications for Use (Describe)
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.
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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Image /page/4/Picture/2 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The font is bold and sans-serif. The logo is simple and recognizable.
510(k) Summary 3M™ Curos Jet™ Disinfecting Cap
General Company Information
| Name: | 3M Company |
|---|---|
| Contact: | Cory J. Hitzman, Ph.D.Regulatory Affairs Specialist |
| Address: | 3M Company, 3M Health Care2510 Conway Ave., Bldg. 275-5NW-06St. Paul, MN 55144-1000 |
| Telephone: | (651) 733-9304 |
| Fax: | (651) 737-5320 |
Date Prepared
February 5, 2020
Subject Device
| Trade Name: | Curos Jet™ Disinfecting Cap |
|---|---|
| Regulation Number: | Unclassified |
| Regulatory Class: | Unclassified |
| Classification Name: | Cap, Device Disinfectant |
| Classification Code: | QBP |
| Classification Panel: | General Hospital |
Predicate/Reference Devices
Same regulatory classifications for Predicate/Reference Devices as the Subject Device above: K111992 - 3M™ Curos™ Disinfecting Cap Predicate Device: Reference Device: K121171 - 3M™ Curos Tips™ Disinfecting Cap
Device Description
The 3M™ Curos Jet™ Disinfecting Cap is a single use, sterile cap that contains 70% Isopropy Alcohol and is intended to disinfect and protect needleless connectors. The Curos Jet™ Disinfecting Cap is translucent green in color. The device consists of a molded high-density polyethylene (HDPE) cap designed to fit onto female threads of a needleless connector, containing a HDPE plunger within. This plunger, when the cap is screwed onto a connector, travels towards a reservoir of 70% Isopropyl Alcohol, releasing it onto the needleless connector for disinfection. The Curos Jet™ Disinfecting Cap is offered in one size only, however it is packaged in "single" (1-cap) and "strip" (5-cap) configurations on a foil seal.
Intended Use (Indications)
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus. Staphylococus epidermidis. Escherichia coli. Pseudomonas aeruqinosa. Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.
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Comparison with Predicate/Reference Devices
| Characteristic | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Device Name | Curos Jet™ Disinfecting Cap | Curos™ Disinfecting Cap | Curos Tips™ Disinfecting Cap |
| Common Name | Cap, Device Disinfectant | Cap, Device Disinfectant | Cap, Device Disinfectant |
| 510(k) # | Not Assigned | K111992 | K121171 |
| Manufacturer | 3M Company | 3M Company | 3M Company |
| RegulationNumber,Product Code | Unclassified, Pre-amendment device, product code: QBP | Unclassified, Pre-amendment device, product code: QBP | Unclassified, Pre-amendment device, product code: QBP |
| Indicationsfor Use | The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility. | The Curos ™ Disinfecting Cap is intended for use on swabbable luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. Curos will disinfect the valve three (3) minutes after application and act as a physical barrier to contamination for up to seven (7) days (168 hours) if not removed. The effectiveness of Curos protectors were tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata and Candida albicans and was found to have >4 log reduction. The Curos Port Protector may be used in the home or healthcare facility. | The Curos Tips ™ disinfecting cap is intended for use as a disinfecting cleaner on male luer connections only and to act as a cover between line accesses. The Curos Tips disinfecting cap will disinfect the male luer one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of Curos Tips disinfecting cap was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have > 4 log reduction. The Curos Tip disinfecting cap may be used in the home or healthcare facility. |
| ConnectionSite | Needleless Luer Connectors | Needleless Luer Connectors | Male Luer Connections |
| Cap Materials | Molded Cap: HDPEMolded Plunger: HDPE | Molded Cap: HDPEMolded Insert: HDPEFoam: Polyurethane | Molded Cap: HDPEMolded Plunger: HDPE |
| Characteristic | Subject Device | Predicate Device | Reference Device |
| Disinfectant -ActiveIngredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol |
| MinimumDisinfectantTime | One (1) Minute | Three (3) Minutes(Data on File SupportsOne (1) Minute) | One (1) Minute |
| MaximumDisinfectantTime | Seven (7) Days | Seven (7) Days | Seven (7) Days |
| DisinfectantDelivery | IPA Reservoir (viaHDPE plungercompression) | IPA Reservoir (via foamsponge compression) | IPA Reservoir (viaHDPE plungercompression) |
| Cap Length | 0.46 inches | 0.36 inches | 0.78 inches |
| Cap Diameter | 0.54 inches | 0.54 inches | 0.31 inches |
| Colorants Used | Translucent Green inmolded HDPE, 3%concentration | Translucent Green inmolded HDPE, 3%concentration | Translucent Green inmolded HDPE, 3%concentration |
| ProvidedSterile | Yes | Yes | Yes |
| Single UseDevice | Yes | Yes | Yes |
| PlasticHousing toremain in place | Yes | Yes | Yes |
| UserPopulation | Home and Hospital Use | Home and Hospital Use | Home and Hospital Use |
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Comparison of Technological Characteristics with the Predicate Device
The Subject Device and Predicate Device are both based on the same technological elements:
- Both are disinfectant caps for use with needleless connectors ●
- Both utilize IPA as the disinfectant
- . Both are mechanically secured to the needleless connector
- Both are sterilized via gamma irradiation ●
- Both are indicated for home and hospital use
There are two functional characteristics that do differ when comparing the Subject Device to the Predicate Device (these characteristics do not differ when comparing to the Reference Device, demonstrating these changes are not novel):
- Minimum time required for disinfection:
- Subject Device: 1 minute O
- Predicate Device = 3 minutes (data on file at 3M Company to support 1 minute) o
- Reference Device: 1 minute O
- . IPA disinfectant delivery:
- Subject Device: HDPE Plunger compression o
- Predicate Device: Sponge compression O
- Reference Device: HDPE Plunger compression O
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These differences in minimum time for disinfection and IPA disinfectant delivery do not affect the performance of the Subject Device, demonstrated through acceptable device functional, efficacy, biocompatibility, sterility, and packaging test results as described below.
Substantial Equivalence Performance Testing
3M Company has provided non-clinical performance test data for the Curos Jet™ Disinfecting Cap Subject Device that demonstrates the pre-defined acceptance criteria for a disinfecting device have been met. This acceptance criterion is defined as a ≥ 4 Log count reduction of two gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa), two gram-positive bacteria (Staphylococcus aureus, Staphylococcus epidermidis), and two fungi (Candida albicans), for one minute. The efficacy testing methodologies and microbes are the same as those tested for the Curos™ Disinfecting Cap Predicate Device cleared under 510(k) K111992 and the Curos Tips™ Disinfecting Cap Reference Device cleared under 510(k) K121171. The efficacy test results for the Subject Device over the three-year shelf life of the product are summarized below.
| Microorganism | Mean Log Reduction(1-Minute) | Mean Log Reduction(7-Day) |
|---|---|---|
| Candida albicans | 5.25 | 5.25 |
| Candida glabrata | 4.53 | 5.46 |
| Escherichia coli | 4.57 | 4.94 |
| Pseudomonas aeruginosa | 5.03 | 5.55 |
| Staphylococcus aureus | 5.36 | 5.15 |
| Staphylococcus epidermis | 4.70 | 5.22 |
Subiect Device Efficacy Test Results
The Curos Jet™ Disinfecting Cap Subject Device cap and packaging performance has been tested to meet pre-specified requirements related to foil seal peel strength, cap retention force to needleless connectors, as well as cap compatibility with needleless connectors via pressure/vacuum leak testing. All testing was completed in accordance with approved company protocols and was completed to demonstrate that the Subject Device seals and acts as a cover for needleless connectors.
The Curos Jet™ Disinfecting Cap Subject Device is sterilized via gamma irradiation using a validated sterilization process which ISO 11137-1:2006 (Sterilization Of Health Care Products -Radiation - Part 1: Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices, FDA Recognition Number 14-528) and the VDma25 method described in ISO 11137-2:2013 (Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose: FDA Recognition Number 14-409). Bioburden testing is in compliance with ISO 11737-1:2018 (Sterilization of health care products – Microbiological methods – Part 1: Determination of the population of microorganisms on product; FDA Recognition Number 14-514) while suitability of the sterility test methodology is in compliance with ISO 11737-2:2009 (Sterilization of medical devices -Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process; FDA Recognition Number 14-327).
The Curos Jet™ Disinfecting Cap Subject Device sterile barrier foil lid complies with ISO 11607-1:2006 (Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems; FDA Recognition Number 14-454). Packaging validation activities comply with ISO 11607-2:2006 (Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes; FDA Recognition Number 14-455). The packaging validation activities demonstrated the foil lid maintains product sterility, form, and function over the 3-vear shelf life.
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Biocompatibility testing has been completed according to ISO 10993-1:2009 (Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing: FDA Recognition Number 2-220) to demonstrate the materials of construction for the Curos Jet™ Disinfecting Cap Subject Device are safe for their intended use and is substantially equivalent to the Predicate Device plus Reference Device. Due to the intended use of the product, the biocompatibility evaluation was completed as a surface device, skin contact, prolonged (< 30 days) exposure. According to FDA guidance and ISO 10993-1:2009, test results included cytotoxicity, sensitization, and irritation.
Clinical Evaluation:
The Curos Jet™ Disinfecting Cap Subject Device, as well as Curos™ Disinfecting Cap Predicate Device and Curos Tips™ Disinfecting Cap Reference Device, are all commercially available in the United States as well as in international markets and were originally classified according to product code LKB (Pad. Alcohol. Device Disinfectant), which was exempt from premarket notification. Therefore, several vears of commercial product experience is available for the Subject Device as well as the Predicate Device and Reference Device. These products have since been reclassified to product code QBP (Cap, Device Disinfectant).
In support of the clinical performance of the Curos Jet™ Disinfecting Cap Subject Device, a review of commercial experience data is provided, comprised of publicly available literature plus product complaints data from the MAUDE database. The dataset supports the proven safety and effectiveness of the Curos Jet™ Disinfecting Cap Subject Device, when used as intended.
Conclusions
The analysis arguments and test results demonstrate the 3M™ Curos Jet™ Disinfecting Cap (Subject Device) is substantially equivalent to the 3M™ Curos™ Disinfecting Cap (Predicate Device).
§ 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.