(62 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier protection of surgical gowns, with no mention of AI or ML.
No
The device is a surgical gown intended to protect operating room personnel and patients from the transfer of microorganisms and bodily fluids, which is a barrier function rather than a therapeutic one.
No
Explanation: The device, a surgical gown, is described as protecting surgical patients and operating room personnel from microorganism transfer. This function is preventative, not diagnostic, as it does not detect, identify, or monitor a disease or condition.
No
The device description explicitly states "Surgical Gowns including various sizes and material," indicating a physical product, not software. The performance studies also focus on material properties and biological safety, which are relevant to physical garments.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate matter during surgical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The device is described as "Surgical Gowns." Surgical gowns are physical barriers worn on the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies listed focus on the physical properties and safety of the material (cytotoxicity, irritation, flammability, fluid resistance, etc.), which are relevant to a barrier device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical gown does not fit that description.
N/A
Intended Use / Indications for Use
International Medsurg Connection's Surgical Gown is intended to be used as Patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter.
This submission includes Surgical Gowns that will be sold both sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Product codes
FYA
Device Description
Surgical Gowns including various sizes and material.
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 / surgical procedures
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)
All material used in the fabrication of the IMC Surgical Gowns were evaluated for:
Cytotoxicity - ISO 10993 - Part 5
Skin Irritation - ISO 10993 - Part 10
Skin Sensitivity - ISO 10993 - Part 11
Systemic Toxicity - ISO 10993 - Part 11
Flammability - 16 CFR Part 1610
Hydrostatic Pressure - AATCC 127
Impact Penetration - AATCC 42
Lint - IST 160.1
Tensile Strength - ASTM D5034
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
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 contains a sequence of handwritten characters, which appear to be 'K052550'. The characters are written in a bold, somewhat stylized font, with varying stroke thicknesses. The overall impression is that of a handwritten code or identifier.
NOV 1 7 2005
SUMMARY OF THE SAFETY AND EFFECTIVENESS 10.0
International Medsurg Connection Surgical Gown
| Manufacturer: | International Medsurg Connection, Inc.
935 N Plum Grove Road, Suite F
Schaumburg, Illinois 60173-4770 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Manny Gupta
Vice President / General Manager
International Medsurg Connection, Inc.
935 N Plum Grove Road, Suite F
Schaumburg, Illinois 60173-4770 |
| Telephone: | 847-619-9929 |
| Date Summary Prepared | August 5, 2005 |
| Product Trade Name: | IMC Surgical Gowns - Multiple |
| Common Name: | Surgical Gown. |
| Classification: | Class II |
| Predicate: | Surgical Gowns, Reference K030364
owned by DeRoyal Industries. |
| Description: | Surgical Gowns including various sizes
and material. |
Intended Use:
International Medsurg Connection's Surgical Gown is intended to be used as Patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
Substantial Eguivalence:
The International Medsurg Connection Surgical Gowns are substantially equivalent to the Surgical Gown sold by DeRoyal Industries, Reference K030364.
1
IMC GOWN LIST
| Catalog Number | Description |
|---|---|
| Surgical Gowns | |
| 260-2001 | Non reinforced Large |
| 260-2002 | Non reinforced X-Large |
| 260-2003 | Non reinforced XX-Large |
| 260-2101 | Fabric reinforced Large |
| 260-2102 | Fabric reinforced X-Large |
| 260-2103 | Fabric reinforced XX-Large |
| 260-2201 | Poly-reinforced Large |
| 260-2202 | Poly-reinforced X-Large |
| 260-2203 | Poly-reinforced XX-Large |
| 260-2301 | Breathable Large, Extra Long |
| 260-2302 | Breathable X-Large, Extra Long |
| 260-2303 | Breathable XX-Large, Extra Long |
| 260-9211 | Fabric reinforced Large, Extra Long |
| 260-9212 | Fabric reinforced X-Large, Extra Long |
| 260-9115 | Non reinforced Large, Extra Long |
| 260-9116 | Non reinforced X-Large, Extra Long |
2
They provide the following characteristics: Intended use is the same Similar configurations Similar materials
Summary of testing:
Comments of the country and secures with and
All material used in the fabrication of the IMC Surgical Gowns were evaluated for:
| Test | Standard |
|---|---|
| Cytotoxicity | ISO 10993 - Part 5 |
| Skin Irritation | ISO 10993 - Part 10 |
| Skin Sensitivity | ISO 10993 - Part 11 |
| Systemic Toxicity | ISO 10993 - Part 11 |
| Flammability | 16 CFR Part 1610 |
| Hydrostatic Pressure | AATCC 127 |
| Impact Penetration | AATCC 42 |
| Lint | IST 160.1 |
| Tensile Strength | ASTM D5034 |
3
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The bird is facing to the right.
Public Health Service
NOV 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Manny Gupta Vice President/General Manager International Medsurg Connection, Incorporated 935 North Plum Glove Road, Suite F Schaumburg, Illinois 60173-4770
Re: K052550
:
Trade/Device Name: IMC Surgical Gowns-Various Sizes and Configurations, Per Attached List Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 3, 2005 Received: November 7, 2005
Dear Mr. Gupta:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
4
Page 2 - Mr. Gupta
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sujite H. Michie Dnd
Čhiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510K Number : _ K O52550
Device name: IMC Surgical Gowns – Various sizes and configurations per attached list
Indication For Use:
This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter.
This submission includes Surgical Gowns that will be sold both sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Prescription Use X (Partb21 CFR 801 Subpart D) AND/OR
Over-The counter Use (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)
Shinda H. Murphy, KD 11/17/05
(Division Sign-off)
Division of anesthesiology, General Hospital. Infection Control Dental Devices