(392 days)
Prevantics® Device swab contains a 3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab is intended for use to disinfect needleless access sites prior to use.
The Prevantics® Device swab is available as a 2 in. x 2 in. swab which contains a 1mL solution (3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol). The product is intended for single, non-sterile use and is not made with natural rubber latex. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions. The subject device is composed of materials that have been successfully and safely used in medical devices including the predicate devises.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Prevantics® Device Swab:
Device: Prevantics® Device Swab (3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab)
Intended Use: Disinfect needleless access sites prior to use.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold in a single, dedicated table, but rather presents performance goals and then the results. Based on the "Time-Kill Study" and "Simulated Use Study," the implied acceptance criterion for efficacy appears to be a >4.0 log10 reduction in CFU/mL (for MEC and Simulated Use) and >5.0 log10 reduction in CFU/mL (for Time-Kill Study) for various microorganisms.
| Acceptance Criterion (Implied) | Reported Device Performance (Prevantics® Device Swab) |
|---|---|
| Time-Kill Study: ≥ 5.0 log10 reduction in CFU/mL at 15 & 30 seconds for specified microorganisms. | Achieved: >5.00 log10 reduction in CFU/mL for all six (6) tested microorganisms (Escherichia coli, Staphylococcus aureus, Candida albicans, Enterococcus faecalis, Pseudomonas aeruginosa, Candida glabrata) at both 15 and 30 seconds. (e.g., E. coli, S. aureus, C. albicans, E. faecalis, P. aeruginosa, C. glabrata all showed ≥ 5.76 log10 reduction). |
| Minimal Effective Concentration (MEC) Study: ≥ 4.0 log10 reduction in CFU/mL at 15 & 30 seconds when diluted to 50% nominal concentration. | Achieved: >4.00 log10 reduction in CFU/mL for all three (3) tested microorganisms (Staphylococcus aureus, Escherichia coli, and Candida albicans) at both 15 and 30 seconds, even when diluted to 50% of the nominal concentration. |
| Simulated Use Study: ≥ 4.0 log10 reduction in microbial CFU/mL for a range of microorganisms (comparable to predicate). | Achieved: Produced a >4.0 log10 reduction in microbial CFU/mL for seven (7) of eight (8) tested microorganisms (Candida albicans, Candida parapsilosis, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus MRSA, Staphylococcus aureus, Staphylococcus epidermidis) regardless of soil conditions. The only microorganism that did not consistently meet the >4.0 log10 reduction was Staphylococcus epidermidis MRSE, but the predicate device also failed for two organisms (Candida parapsilosis and Staphylococcus epidermidis MRSE). The overall conclusion states the device provides "substantially equivalent results to the predicate device." |
Study Details:
The document describes several non-clinical (in-vitro) studies:
2. Sample Size Used for the Test Set and Data Provenance
-
Time-Kill Study:
- Sample Size: Three (3) lots of Prevantics® Device Swab (labeled as Chlorascrub at the time of testing) nearing end of shelf life were tested. For each organism, there were 3 measurements (one per lot). Six microorganisms were tested.
- Data Provenance: In-vitro laboratory study. Not specified if external or internal.
-
Minimal Effective Concentration (MEC) Study:
- Sample Size: Not explicitly stated but implies similar setup to the Time-Kill Study (multiple dilutions, likely across the same 3 lots). Three microorganisms were tested.
- Data Provenance: In-vitro laboratory study.
-
Simulated Use Study:
- Sample Size: Three (3) lots of Prevantics® Device Swab were tested against eight (8) microorganisms, both with and without soil conditions. The predicate device (Curos® Port Protector) was also tested for comparison. For each microorganism under each condition (soil/no-soil), there are mean log10 reductions provided for each of the 3 lots of Prevantics and an overall mean for Prevantics, plus a mean for Curos. This implies multiple replicates per lot per organism/condition.
- Data Provenance: In-vitro laboratory study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The studies performed are in-vitro microbiological tests, not human-reader-based assessments. Therefore, the concept of "experts" establishing ground truth in the context of clinical interpretation or image reading is not applicable here. The ground truth is microbiological (e.g., actual colony forming unit counts).
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human readers interpret data, and discrepancies need to be resolved. Since these are in-vitro microbiological studies, an adjudication method is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. The studies are in-vitro microbiological tests comparing the device's efficacy against microorganisms, and in one case, against a predicate device's in-vitro performance. There is no human reader component.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a physical medical device (a swab with disinfectant), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The studies performed assess the standalone performance of the device itself (its disinfectant properties) in an in-vitro setting.
7. The Type of Ground Truth Used
The ground truth used in these studies is microbiological quantitative data, specifically:
- Direct counts of Colony Forming Units (CFU/mL) for microbial cultures.
- Log10 reduction in CFU/mL from baseline/control.
8. The Sample Size for the Training Set
The concept of a "training set" applies to machine learning or AI models. Since this device is a physical product (a disinfectant swab) and not an AI system, there is no training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI model, this information is not applicable.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2014
Professional Disposables International, Inc. Ms. Elizabeth Ernst Senior Director, Regulatory & Medical Affairs Two Nice-Pak Park Orangeburg, NY 10962
Re: K132380
Trade/Device Name: Prevantics® Device Swab Regulation Number: Unclassified Regulation Name: Pad, Alcohol, Device Disinfectant Regulatory Class: Unclassified Product Code: LKB Dated: July 31, 2014 Received: August 1, 2014
Dear Ms. Ernst:
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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Page 2 - Ms. Ernst
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/Resourcesfor You/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 vours.
Erin |. Keith -S
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
510(k) Number (if known) K132380
Device Name Prevantics® Device Swab
Indications for Use (Describe)
Prevantics® Device swab contains a 3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab is intended for use to disinfect needleless access sites prior to use.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Saiiad H.
Digitally signed by Sajjad H. Syed -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Sajjad H. Syed -S, 0.9.2342.19200300.100.1.1=2000601742 Date: 2014.08.27 09:51:06 -04'00'
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Section 5: 510(K) Summary Statement 21(CFR 807.92)
| 510 K Summary | |
|---|---|
| Manufacturer Name | Professional Disposables International, Inc. |
| Contact Name | Elizabeth Ernst |
| Title | Senior Director, Regulatory & Medical Affairs |
| Postal Address: | 100 Phillips Parkway, Montvale, NJ 07645 |
| Fax: | 845-398-5347 |
| Date: | 7/29/2014 |
| Device ProprietaryNames | Prevantics® Device swab |
| Device Common orUsual Name | Chlorhexidine Gluconate (3.15%)* and Isopropyl Alcohol (70%) Swab |
| Classification Code | LKB |
| Classification Panel | General Hospital |
| Regulation Number | N/A |
| Predicate Device | Substantial equivalence is claimed to the following devices as related tointended use and design characteristics:Curos® Port Protector, Ivera Medical Corp. (K080466)BD Alcohol Swab, BD Medical – Medical Surgical Systems (K121655) |
| Description of the Device | The Prevantics® Device swab is available as a 2 in. x 2 in. swab whichcontains a 1mL solution (3.15% Chlorhexidine Gluconate and 70% (v/v)Isopropyl Alcohol). The product is intended for single, non-sterile use andis not made with natural rubber latex. The subject device is not intendedto treat existing infections. The device is not intended to have any effecton contaminated infusion solutions. The subject device is composed ofmaterials that have been successfully and safely used in medical devicesincluding the predicate devises. |
| Intended Use of theDevice: | Prevantics® Device swab is intended for needleless access sitedisinfection. |
| TechnologicalCharacteristics | The Prevantics® Device Swab has a similar intended use as its predicatedevice for disinfecting needleless access sites with the home or healthcarefacility. It is provided non-sterile and is constructed with 3.15%chlorhexidine gluconate and the same 70% isopropyl alcohol as itspredicate devices. It varies in technological characteristics as compared totwo (2) of the predicate devices as the subject device is a nonwoven padsaturated with chlorhexidine gluconate (3.15%) and isopropyl alcohol(70%) and the predicate devices are either an alcohol pad (BD AlcoholPad) or contain an alcohol pad-like sponge within a rigid cap design likeIvera's Curos® Port Protector. |
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Prevantics® Device swab Section 5: 510(K) Summary Statement 21(CFR 807.92) Professional Disposables International, Inc.
| 510K Number | K121655 | K080466 | |
|---|---|---|---|
| Product Code | LKB | LKB | LKB |
| Device Name | Prevantics® Device Swab | BD Alcohol Swab | Curos® Port |
| Manufacturer | Professional DisposableInternational Inc | BD Medical - Medical SurgicalSystems | Ivera Medical Corporation |
| Intended Use | When used for scrubbing for 5seconds and drying for 5seconds, Prevantics® DeviceSwab (a single use device) willdisinfect needleless access sitesprior to access. | Is a single use, sterile device containing70% Isopropyl alcohol. When used forscrubbing for 5 seconds and allowingdrying for 5 seconds, the device willdisinfect needleless access sites prior touse. | Is a device containing 70%alcohol, intended for use onswabbable luer access valves as adisinfecting cleaner prior to lineaccess and to act as a physicalbarrier to contamination betweenline accesses. The device willdisinfect the valve three (3)minutes after application and actas a physical barrier tocontamination for up to seven (7)days (168 hours) if not removed. |
| AdditionalClaims | Not made with natural rubberlatex | ||
| AntimicrobialAgent | Chlorhexidine Gluconate(3.15%) and Isopropyl Alcohol(70%) | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol |
| UserPopulation | It may be used in the home orhealthcare facility. | It may be used in the home orhealthcare facility. | The Curos® Disinfecting PortProtector may be used in the homeor healthcare facility. |
| Sterilization | Non-sterile | Terminally Sterile (Unknown Method) | Gamma Irradiated |
| Packaging | Individually wrapped | Individually wrapped | Individually wrapped |
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PDI performed multiple non-clinical tests in support of this 510k submission. Testing included the following: a time kill study involving (two gram positive, two gram negative and 2 fungi) evaluated at multiple time points (15 and 30 sec), a minimum effective concentration (MEC) study (tested at 15 and 30 seconds) and a simulated use study.
Time-Kill Study
A time-kill study was performed (based on ASTM E2315 - 03(2008) Standard Guide for Assessment of Microbial Activity Using a Time-Kill Procedure) to determine how rapidly and effectively Prevantics® Device Swab kills a variety of microorganisms. Three (3) lots Prevantics® Device Swab nearing end of shelf life were tested. (Three lots of the devices were labeled as Chlorascrub. This was the device name prior to rebranding. The devices will be referred to as Prevantics® Device Swabs throughout this document.) Sterile Water for Injection was used as a control.
Six microorganisms were tested: two (2) Gram positive, two (2) Gram negative and 2 fungi (Staphylococcus aureus (ATCC #6538). Enterococcus faecalis (ATCC #29212). Escherichia coli (ATCC #11229), Pseudomonas aeruginosa (ATCC #15442), Candida albicans (ATCC #10231), and Candida glabrata (ATCC #2001). At both 15 and 30 seconds, application of the Prevantics Device Swab solution to the microbial cultures resulted in a >5.00 log10 reduction in CFU/mL for each of the six (6) microorganism listed above.
| Mean Log10 Reduction | |||
|---|---|---|---|
| Microorganism | Test Substance | 15 sec | 30 sec |
| Escherichia coli(ATCC #11229) | Chlorascrub SwabLot No. 11200159 | 6.07 | 6.07 |
| Chlorascrub SwabLot No. 11200247 | 6.07 | 6.07 | |
| Chlorascrub SwabLot No. 11200251 | 6.07 | 6.07 | |
| Sterile WaterLot No. 25065031 | 0.01 | 0.02 | |
| Staphylococcus aureus(ATCC #6538) | Chlorascrub SwabLot No. 11200159 | 6.00 | 6.00 |
| Chlorascrub SwabLot No. 11200247 | 6.00 | 6.00 | |
| Chlorascrub SwabLot No. 11200251 | 6.00 | 6.00 | |
| Sterile WaterLot No. 25065031 | -0.01 | 0.06 | |
| Candida albicans(ATCC #10231) | Chlorascrub SwabLot No. 11200159 | 5.88 | 5.88 |
| Chlorascrub SwabLot No. 11200247 | 5.88 | 5.88 | |
| Chlorascrub SwabLot No. 11200251 | 5.88 | 5.88 | |
| Sterile WaterLot No. 25065031 | 0.07 | -0.01 |
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Prevantics® Device swab Section 5: 510(K) Summary Statement 21(CFR 807.92) Professional Disposables International, Inc.
| Microorganism | Test Substance | Mean Log10 Reduction | |
|---|---|---|---|
| 15 sec | 30 sec | ||
| Enterococcus faecalis(ATCC #29212) | Chlorascrub SwabLot No. 11200159 | 5.76 | 5.76 |
| Chlorascrub SwabLot No. 11200247 | 5.76 | 5.76 | |
| Chlorascrub SwabLot No. 11200251 | 5.76 | 5.76 | |
| Sterile WaterLot No. 25065031 | 0.07 | 0.14 | |
| Pseudomonas aeruginosa(ATCC # 15442) | Chlorascrub SwabLot No. 11200159 | 6.46 | 6.46 |
| Chlorascrub SwabLot No. 11200247 | 6.46 | 6.46 | |
| Chlorascrub SwabLot No. 11200251 | 6.46 | 6.46 | |
| Sterile WaterLot No. 25065031 | 0.20 | 0.23 | |
| Candida glabrata(ATCC #2001) | Chlorascrub SwabLot No. 11200159 | 6.07 | 6.07 |
| Chlorascrub SwabLot No. 11200247 | 6.07 | 6.07 | |
| Chlorascrub SwabLot No. 11200251 | 6.07 | 6.07 | |
| Sterile WaterLot No. 25065031 | 0.16 | 0.19 |
Minimal Effective Concentration (MEC) Study
The minimal effective concentration was examined using a range of dilutions of the Prevantics® Device Swab solution (50 - 90% of nominal). The testing was performed using the same techniques outlined in the Time-Kill Study section above. The microorganisms were limited to one each of Gram positive, Gram negative and fungus (Staphylococcus aureus (ATCC #6538), Escherichia coli (ATCC #11229), and Candida albicans (ATCC #10231)).
At both 15 and 30 seconds, application of the Prevantics® Device Swab solution to the microbial cultures resulted in a >4.00 log10 reduction in CFU/mL for each of the three (3) microorganism listed above. The results indicate that even when diluted to 50% of the nominal concentration, Prevantics Device Swab contains an effective antimicrobial combination.
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Simulated Use Study
Additionally, in-vitro data from a Simulated Use Study is also submitted to substantiate performance that the subject device is substantially equivalent to the predicate devices.
| Mean Log10 Reduction (CFU/mL) of Needless AccessSite After 5 Second Application | ||||||
|---|---|---|---|---|---|---|
| Microorganism | Soil | MeanLot 1 | MeanLot 2 | MeanLot 3 | OverallMeanPrevantics | MeanCuros |
| Candida albicans(ATCC #10231) | No | 6.5 | 6.5 | 4.9 | 6.0 | 6.5 |
| Yes | 6.2 | 6.2 | 6.2 | 6.2 | 5.3 | |
| Candida parapsilosis(ATCC #7330) | No | 7.2 | 5.2 | 7.2 | 6.5 | 2.1 |
| Yes | 4.8 | 5.4 | 3.5 | 4.6 | 2.5 | |
| Escherichia coli(ATCC #25922) | No | 5.7 | 4.9 | 4.4 | 5.0 | 6.3 |
| Yes | 4.8 | 6.2 | 3.1 | 4.7 | 6.2 | |
| Pseudomonas aeruginosa(ATCC #27853) | No | 3.3 | 4.4 | 4.6 | 4.1 | 5.5 |
| Yes | 5.3 | 4.3 | 3.1 | 4.2 | 5.4 | |
| Staphylococcus aureus MRSA(ATCC #33591) | No | 5.1 | 3.6 | 3.4 | 4.1 | 6.5 |
| Yes | 6.6 | 4.9 | 4.9 | 5.5 | 4.3 | |
| Staphylococcus epidermidis MRSE(ATCC #51625) | No | 2.3 | 2.8 | 2.3 | 2.4 | 2.7 |
| Yes | 4.6 | 3.0 | 1.3 | 2.9 | 2.2 | |
| Staphylococcus aureus(ATCC #6538)* | No | 5.8 | 5.5 | 6.2 | 5.8 | 5.5 |
| Yes | 4.7 | 6.1 | 5.4 | 5.4 | 6.2 | |
| Staphylococcus epidermidis(ATCC #12228)* | No | 5.5 | 5.4 | 5.3 | 5.4 | 5.7 |
| Yes | 6.4 | 5.7 | 5.5 | 5.9 | 5.0 |
- The testing of both Staphylococcus aureus and Staphylococcus epidermidis were repeated after the initial results for Staphylococcus epidermidis demonstrated a <3 logio reduction for both predicate and test devices.
The results demonstrate that Prevantics® Device Swab produces a >4.0 log10 reduction in microbial CFU/mL for seven (7) of eight (8) tested microorganisms, regardless of soil conditions. In comparison, the predicate device (Curos® Port Protector) achieved similar >4.0 log10 reduction on six (6) of eight (8) microorganisms. The Curos® Port Protector failed to achieve a >4.0 log10 reduction for Candida parapsilosis (ATCC #7330) and Staphylococcus epidermidis MRSE (ATCC 51625). The results of the simulated use testing indicate that Prevantics® Device Swab provides substantially equivalent results to the predicate device (Curos® Port Protector).
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| Determination of SubstantialEquivalence: | Summary of Non-Clinical Tests |
|---|---|
| A variety of non-clinical tests were conducted to show the safetyand effectiveness of the subject device including comparisonsagainst the predicate devices. Standardized test methods from ISO-10993 were used in this testing and the methods and results aredescribed in the submission. | |
| Summary of Clinical TestsNo new clinical tests were required to support the change.The review of the indications for use, the technical characteristicsand the results provided from the non-clinical tests performed tosatisfy International Standard ISO-10993, Biological Evaluation ofMedical Devices Part 1: Evaluation and Testing (Cytotoxicity,Closed Patch Test, Dermal Irritation, Systemic Toxicity)demonstrate that Prevantics® Device Swabs are substantiallyequivalent to the predicate devices. |
- Conclusion Prevantics® Device Swab shares the same indications for use, similar design and functional features and was found to be substantially equivalent to the predicate devices. Prevantics® Device Swab has the same intended use as the predicate; and while it has different technological characteristics, the information submitted to FDA does not raise new questions of safety and effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed devices.
This summary includes all information necessary and Professional Disposable International Inc will provide any additional information requested by FDA during review of the 510(k).
Professional Disposable International Inc verifies that the following criteria have been met.
- The summary includes only information that is also covered in the body of the 510(k). .
- The summary does not contain any puffery or unsubstantiated labeling claims. .
- The summary does not contain any raw data, i.e., contains only summary data. ●
- The summary does not contain any trade secret or confidential commercial information. .
- The summary does not contain any patient identification information. .
N/A