(74 days)
Not Found
Not Found
No
The 510(k) summary describes a disposable surgical respirator and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a particulate respirator for use by operating room personnel during surgical procedures to protect the wearer, not to treat a patient.
No
The device is described as a "Particulate Respirator" intended to protect the wearer during surgical procedures. Its function is to filter particles, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly states it is a "Disposable Surgical N95 Particulate Respirator," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Gerson Model 2130/2131 Disposable Surgical N95 Particulate Respirators are designed to be worn by individuals to protect them from airborne particles and transfer of material. They are a barrier device, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states protection of the wearer from transfer of material and particulate material during surgical procedures. This is a personal protective equipment (PPE) function, not an in vitro diagnostic function.
Therefore, based on the provided information, this device falls under the category of personal protective equipment (PPE) and is not an IVD.
N/A
Intended Use / Indications for Use
The Gerson Model 2130 /2131 Disposable Surgical N95 Particulate Respirators are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and particulate material from transfer. The respirator is a single-use disposable. The 2130 and 2131 Model respirators are available in either blue or white colors. This device also meets CDC Guidelines for TB Exposure Control.
Product codes
MSH
Device Description
Not Found
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling a human figure with outstretched arms.
Public Health Service
APR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Brunell Regulatory Affairs Louis M. Gerson Company Limited 15 Sproat Street Middleboro, Massachusetts 02346
Re: K050193
KU50193
Trade/Device Name: 2130 /2131 Surgical N95 Particulate Respirators(Blue or White) Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: December 1, 2005 Received: January 27, 2005
Dear Mr. Brunell:
We have reviewed your Section 510(k) premarket notification of intent to market the device We flave reviewed your Bection 970(-1) personally equivalent (for the referenced above and have determined and acreed predicate devices marketed in indications for use stated in the choloral of to enactment date of the Medical Device interstate conmisece prior to that have been reclassified in accordance with the provisions of Amendments, of to devices that harts one (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment of therefore, market the device, subject to the general approval application (11MT). 178 - 178 - 178 general controls provisions of the Act include confors provisions of the rea. "The genting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see a0010) into enner its. Existing major regulations affecting (PMA), il may be subject to such additional controllations, Title 21, Parts 800 to 898. In the Coderal your device can be found in the Code of Peacharing your device in the Federal Register.
1
Page 2 - Mr. Brunell
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a substant in a such issues with other requirements mean that FDA has made a decemination that Joan inistered by other Federal agencies.
of the Act or any Federal statutes and regulations and limited to: posicreting of the Act of any rederal statutes and registerents, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing programs a You must comply with an the Act 3 requirements and 801); good manufacturing practice and listing (21 CFK Part 807), labeling (21 OFF CF arrestigation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Pat 820); requirements as set form in the quality systems (QB) regarites (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 a This letter will anow you to begin mailer.ing your device of your device to a
premarket notification. The FDA finding of substantial equivalers and thus, per premarket nothleation. The PDA midning of basemand of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de recolor of the Also, please note the regulation please contact the Othec or Comphanee at (210) = 10 = 1 Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21 CFR Part from the may obtain other general information on your responsibilities under the Act from the may obtain other general mionmation on your respective at its toll-free DIVIsion of Simall Manufacts of Sill, 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ 2130 /2131 Surgical N95 Particulate Respirators( Blue or White)
Indications For Use:
The Gerson Model 2130 /2131 Disposable Surgical N95 Particulate Respirators are intended to be worn by operating room personnel during surgical procedures to protect intendou to bo worn by operating room personnel from transfer of both the burglour patient and particulate material. The respirator is a single-use disposable.
The 2130 and 2131 Model respirators are available in either blue or white colors.
This device also meets CDC Guidelines for TB Exposure Control.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ x _____________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aida P. Murgheis 4/4/45
Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
Page 1 of 1
Number. 450 143