(127 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is a surgical mask intended to protect against the transfer of microorganisms, blood, and body fluids, not to treat a disease or health condition.
No
The device description clearly states its purpose is to protect from transfer of microorganisms, blood, and airborne particulate materials, not to diagnose a condition.
No
The device description clearly outlines physical components like spunbonded polypropylene, meltblown polypropylene, urethane elastic fiber, and an aluminum strip, indicating it is a hardware device (a surgical mask).
Based on the provided information, the Tiger SFM0001 surgical mask is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting individuals from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask (layers, materials, ear-loops, nose piece). There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The surgical mask does not perform any such function.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility), which are relevant to its barrier function, not diagnostic accuracy.
Therefore, the Tiger SFM0001 surgical mask is a medical device, but it falls under the category of a personal protective equipment (PPE) or a barrier device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tiger surgical mask SFM0001 (colors: blue) is intended for single use by operating room personnel or general health care workers for protection against microscopic organisms, body fluids and particulates. These would include use procedure mask, isolation mask or dental.
The Tiger SFM0001 surgical mask is intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Tiger surgical mask SFM0001 (colors: blue) is flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown polypropylene filter material; Ear-loops are made of urethane elastic fiber for free elastic loops. The nose piece is white aluminum strip with PP covering. All of the materials used in the construction of the Tiger flat surgical Masks are being used in currently marketed devices (see predicate information). All items are nosterilize and only for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel or general health care workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Discussion of Non-clinical Test Performed for Determination of Substantial Equivalence are as follows:
NELSON Fluid Resistance-Resistance of Liquid (Synthetic Blood Penetration I. Resistance) ASTM F 1862
NELSON Bacterial Filtration Efficiency (BFE) test ASTMF2101 II.
NELSON Particulate Filtration Efficiency (Latex Particule Challenge ASTM F2299) III.
NELSON Flammability, Complied with 16 CFR 1610 Class L IV.
V. TOXIKION Biocompatibility per ISO 10993
It is our conclusion that performance testing meet all relevant requirements of the aforementioned test standard.
Discussion of Clinical Tests Performed.
Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid resistance: 31 of 32 Pass at 120mmHg
Particulate Filtration Efficiency: >99.9% at 2.7µm
Bacterial Filtration Efficiency: 99.86%
Flammability Class: 1
Delta-P: 3.78
Biocompatibility: Cytotoxictiy: no cyctotoxitial potential, Sensitization: negligible, Irritation: No reactions
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Tiger Medical Group. The logo consists of a circular emblem on the left and the text "Tiger Medical" on the right. Below "Tiger Medical" is the word "Group" in a smaller font size. The emblem appears to be a stylized image, possibly representing a tiger or a medical symbol.
Page 1 of 2
510(k) Summary
JAN 2 5 2011
This summary of 510K safety and effectiveness information is being submitted in accrodance with the requirements of 21 CFR 807.92.
The assigned 510K number is
- Submitter's Identification:
Tiger Medical Products Ltd
Liulin Tower, STE 1910
1 Huai Hai Zhong Road
Shanghai 200021
P.R.China
Contact:
Maggie Zhong
Tel:+86-21-33907930
Fax:+86-21-33907932
Mail: maggie-zhong2001@vip.sina.com
Date of Summary: March 8th, 2010
-
- Device Name:
Tiger Surgical Mask
- Device Name:
-
- Classification Name: Surgical Mask
-
4.. Device Description
The Tiger surgical mask SFM0001 (colors: blue) is flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown polypropylene filter material; Ear-loops are made of urethane elastic fiber for free elastic loops. The nose piece is white aluminum strip with PP covering. All of the materials used in the construction of the Tiger flat surgical Masks are being used in currently marketed devices (see predicate information). All items are nosterilize and only for single use.
5. Intended Use:
Tiger surgical mask SFM0001 is intended for single use by operating room personnel or general health care workers for protection against microscopic organisms, body fluids and particulates. These would include use procedure mask, isolation mask or dental
6. Comparison to Predicate Devices
Tiger surgical mask SFM0001(color: blue) substantially equivalent is safety and effectiveness to the predicate devices.
Tucker & Associates company-K022256 Surgical face masks white, yellow, pink, blue and green
Prestige Ameritech-K061716 Prestige Ameritech Face Mask (multiple labels)
1
Image /page/1/Picture/1 description: The image shows the logo for Tiger Medical Group. The logo consists of a circular emblem on the left and the text "Tiger Medical" on the right. Below "Tiger Medical" is the word "Group". The emblem appears to contain the letters TMG.
Page 2 of 2
| Performance Characteristics | Test method | Acceptance criteria/result | Predicate
results | Predicate device | Predicate device results |
|-----------------------------------------|-------------|---------------------------------------------|----------------------|------------------|--------------------------|
| | | Tiger surgical mask
SFM0001 | K061716 | | K022256 |
| Fluid resistance | ASTM 1862 | 31 of 32 Pass at 120mmHg | 29 of 32 pass | | No visual penetration |
| Particulate
Filtration
Efficiency | ASTM F2299 | >99.9% at 2.7µm | 2.0 microns | | 98.5% at 0.1 microns |
| Bacterial Filtration Efficiency | ASTM F2101 | 99.86% | 99.6% | | 97.9% |
| Flammability Class | 16CFR 1610 | 1 | 1 | | 2 |
| Delta-P | Mil M36954C | 3.78 | 2.6 | | 1.8 |
| Biocompatibility | ISO10993-1 | Cytotoxictiy: no cyctotoxitial
potential | N/A | | N/A |
| | | Sensitization: negligible | N/A | | N/A |
| | | Irritation: No reactions | N/A | | N/A |
Discussion of Non-clinical Test Performed for Determination of Substantial Equivalence are as follows:
NELSON Fluid Resistance-Resistance of Liquid (Synthetic Blood Penetration I. Resistance) ASTM F 1862
NELSON Bacterial Filtration Efficiency (BFE) test ASTMF2101 II.
NELSON Particulate Filtration Efficiency (Latex Particule Challenge ASTM F2299) III.
NELSON Flammability, Complied with 16 CFR 1610 Class L IV.
V. TOXIKION Biocompatibility per ISO 10993
It is our conclusion that performance testing meet all relevant requirements of the aforementioned test standard.
Discussion of Clinical Tests Performed.
Not Applicable
- Conclusions
Tiger surgical mask SFM0001 has the same intended use and technology characteristics as the predicate devices (K022256,K061716). Moreover, the bench testing contained in this submission supplied demonstrate that the technological characteristics do not raise any new question of safety or effectiveness. Therefore, the Tiger SFM0001 flat surgical mask is substantially equivalent to the predicate devices.
Confidential - Property of Tiger Medical Group - Not To Be Used Without Written Authorization by Tiger Medical Group
2
Standards & Regulations Declaration of Conformity
| As manufacturer | Tiger Medical Products Ltd |
|---|---|
| Liulin Tower, STE 1910 | |
| 1 Huai Hai Zhong Road | |
| Shanghai 200021 | |
| P.R.China |
We declare that SFM0001 flat surgical masks are conforms to standards/ regulations listed herein according to FDA requirements.
Standards & regulations declaration of conformity
| Reference | Description | Test Laboratories | Comments |
|---|---|---|---|
| ASTM F1862 | Synthetic Blood Penetration | ||
| Resistance | Nelson Laboratories | Refer to test report | |
| ASTM F2101-01 | Bacterial Filtration | ||
| Efficiency(BFE) and Delta-P | Nelson Laboratories | Refer to test report | |
| ASTM F2299 | Particulate Filtration Efficiency | Nelson Laboratories | Refer to test report |
| 16 CFR 1610 | Flammability 16 | Nelson Laboratories | Refer to test report |
| ISO10993-5 | Cytotoxicity | Toxikon Corporation | Refer to test report |
| ISO10993-10 | Irritation & Sensitization | Toxikon Corporation | Refer to test report |
(Signature)
Elaine M. Young
(Typed Name) Elaine M Fong
(Date) March 8, 2010 503
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
Ms. Maggie Zhong Consultant Tiger Medical Products, Limited Liulin Tower, STE 1910 1 Huai Hai Zhong Road Shanghai 200021 P.R. China
JAN 2 5 2011
Re: K102713
Trade/Device Name: Tiger Surgical Mask for single use Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: December 23, 2010 Received: January 10, 2011
Dear Ms. Zhong:
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. Bearing of the country of the county of the county of 11.11
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Page 2- Ms. Zhong
Enclosure
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
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INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): K 1027 / 3
APPLICANT: Tiger Medical Products Ltd
DEVICE NAME: Tiger Surgical Mask for single use
INDICATION FOR USE:
The Tiger SFM0001 surgical mask is intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use X (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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Elizabeth F. Camine-Willee
(Division Sign-Off)
al Profon Olgh-Olf)
Division of Anesthesiology, General Hospital and Control of AneSthesiology, General Devices
510(k) Number: K102713
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