K093161 · Glaxosmithkline Consumer Healthcare · ONT · May 10, 2010 · General, Plastic Surgery
Device Facts
Record ID
K093161
Device Name
ACTIPROTECT UF N95 RESPIRATOR
Applicant
Glaxosmithkline Consumer Healthcare
Product Code
ONT · General, Plastic Surgery
Decision Date
May 10, 2010
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 878.4040
Device Class
Class 2
Indications for Use
Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007) ) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
Device Story
Single-use, flat-fold N95 filtering facepiece respirator; consists of multiple non-woven fabric layers. Filtration achieved via mechanical entrapment and surface electrostatic attraction. Outer layer coated with Virucoat™ (1.8% citric acid) to inactivate 99.99% of influenza A viruses upon contact. Secured to face via two synthetic elastic straps. Used in occupational settings; worn by healthcare workers or other personnel. Provides physical barrier against airborne particulates and fluid splashes. Benefits include potential reduction in viral load on respirator surface, though clinical efficacy in preventing infection compared to uncoated respirators is not established.
Clinical Evidence
No clinical efficacy studies conducted. Safety evidence limited to human repeated insult patch testing (n=not specified) to assess skin sensitization and irritation; results showed no adverse reactions.
Indicated for occupational use by individuals during seasonal influenza A or influenza A pandemic to cover nose and mouth; reduces wearer exposure to pathogenic biological airborne particulates and protects against splash/spray of body fluids.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Image /page/0/Picture/3 description: The image shows the logo for GlaxoSmithKline. The logo consists of the letters "gsk" in white, set against a black circle. To the right of the circle, the full name "GlaxoSmithKline" is written in black.
# GlaxoSmithKline
1500 Littleton Road Parsippany, NJ 07054-3884
Tel. 973 889 2100 Fax. 973 889 2390 www.gsk.com
### 6. 510(k) Summary
### 6.1 Applicant and Correspondent:
Name: GlaxoSmithKline Consumer Healthcare
Address: 1500 Littleton Road Parsippany, NJ 07054-3884
Contact Person: Zinatara A. Manji, M.S., Pharm.D. Director, Regulatory Affairs Phone: (973)-889-2100
Date of Preparation: September 30, 2009
#### 6.2 Manufacturer:
Sperian Protection Armor SAS ZI de la Gare 22940 Plaintel France
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#### 6.3 Name of Device:
| Trade/Proprietary/Model Name: | Actiprotect™ UF N95 Respirator<br>Double Strap, Flat Fold |
|-------------------------------|-------------------------------------------------------------------------------------------------------|
| Common Name: | Filtering Facepiece Respirator |
| Classification Name: | Filtering Facepiece Respirator for Use by<br>Healthcare Workers (21 CFR 878.4040)<br>Product Code ONT |
### Devices to Which New Device is Substantially Equivalent: 6.4
Actiprotect™ UF N95 Respirator K081923
#### 6.5 Device Description:
Actiprotect™ UF N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic elastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.
#### 6.6 Statement of Intended Use:
Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna
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A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007) ) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
#### 6.7 Summary of the Technological Characteristics:
Actiprotect™ UF N95 Respirator filters at least 95% of particulates and has a coating on its outermost surface to capture and inactivate influenza viruses on contact with the surface. The predicate device is an N95 respirator: Actiprotect™ UF N95 Respirator, Double Strap Flat Fold.
Actiprotect™ UF N95 Respirator has been tested for and passed standardized tests for fluid penetration resistance, particulate filtration efficiency, bacterial filtration efficiency (BFE), flammability, and breathing resistance.
The materials of construction used in Actiprotect™ UF N95 Respirator are identical to those of the predicate. Therefore the subject device is substantially equivalent to the predicate device. The device as a whole has been demonstrated to be biocompatible by cytotoxicity and human repeated insult patch testing.
## Brief discussion of the nonclinical tests submitted. referenced. 6.8 or relied on in the premarket notification submission for a determination of substantial equivalence:
- . Fluid Penetration Resistance - ASTM F1862
- . Particulate Filtration Efficiency - NIOSH 42 CFR 84.181
- . Bacterial Filtration Efficiency - MIL M36954C, ASTM F2101
- . Flammability - 16 CFR 1610
- . Breathing Resistance - NIOSH 42 CFR 84.180
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## 6.9 Brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:
Human Repeated Insult Patch Tests were conducted using samples of the respirator materials held under occlusive patches. There were no adverse reactions reported during the studies. The outcome of these tests revealed no evidence of sensitization or irritation.
#### 6.10 Conclusions drawn from the nonclinical and clinical tests:
Cytotoxicity and human repeated insult patch tests plus a toxicological review of data on the product's ingredients indicates the product is safe for use in the intended application. Bench testing demonstrated the product's efficacy. Actiprotect™ UF N95 Respirator has been shown to be substantially equivalent to the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
# MAY 1 0,2010
Zinatara A. Manji Ph.D. Director, Regulatory Affairs GlaxoSmithKline Consumer Healthcare GlaxoSmithKline 1500 Littleton Road Parsippany, New Jersey 07054-3884
Re: K093161
Trade/Device Name: Actiprotect TM UF N95 Respirator, Double Strap Flat Fold Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: ONT Dated: March 25, 2010 Received: March 26, 2010
Dear Dr. Zinatara A. Manji:
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- Dr. Zinatara A. Manji
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 (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours,
Susan Runner
*Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, 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):
Device Name: Actiprotect™ UF N95 Respirator, Double Strap Flat Fold
Indications For Use:
Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007) ) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
9
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
signature
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Controloberated Bavices
510(k) Number: k09316
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
