(20 days)
Surgical gowns are devices that are intended to be worn by health care personnel during surgical or other Ourgiour gowns are a vice that and the wearer from transfer of microorganisms, body fluids, and particulate material.
reusable surgical ' gown manufactured with the W.L. Gore ASSIST™ medical fabric in the Critical Zones.
The provided document describes the acceptance criteria and performance data for the SRI/Surgical Express, Inc. SP™ Reusable Surgical Gown, but it does not contain information related to AI or algorithm-driven device performance. The document is a 510(k) premarket notification for a traditional medical device (a surgical gown) and details its physical, biological, and material properties.
Therefore, many of the requested fields (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone algorithm performance, training set sample size, how training set ground truth was established) are not applicable to this document as it does not describe an AI medical device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (as per document) |
|---|---|---|
| Biocompatibility | ISO 10993-1 1997 | Complies with requirements; acceptable test results for washed/dried/sterilized material. |
| Flammability | 16 CFR 1610 Standard (CPSC 1954), Class 1 | Complies with requirements. |
| NFPA 99-1999 regulations | Meets requirements for non-flammable anesthetizing locations. | |
| Barrier Performance | AATCC 42-Impact Penetration | Achieved acceptable results throughout 125 wash/dry/steam autoclave cycles. |
| AATCC 127-Water Resistance: Hydrostatic Pressure Test | Achieved acceptable results throughout 125 wash/dry/steam autoclave cycles. | |
| Physical Properties | Spray Test | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. |
| ASTM D3776-96 (mass per unit area) | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. | |
| ASTM D5035-95 (breaking force/elongation) | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. | |
| ASTM D5587-96 (water vapor transmission) | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. | |
| IES-RP-CC003.3-93 (Helmke drum test) | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. | |
| Sterilization | ANSI/AAMI/ISO 11134:1993 | Validated to meet a Sterility Assurance Level of 10⁻⁶. |
| Care and Handling | ANSI/AAMI ST65: 2000 | Shall be processed in accordance with requirements, manufacturer's instructions, and internal quality system procedures. |
Information Not Applicable or Not Provided in the Document (due to the nature of the device as a non-AI product):
- Sample size used for the test set and the data provenance: Not applicable/Not specified for an AI device. The document mentions "125 wash/dry/steam autoclave cycles" for barrier performance and physical properties testing, which describes the conditions and extent of physical testing, not a dataset for an algorithm. Data provenance (country, retrospective/prospective) is not relevant for this type of testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI devices (e.g., expert annotations on images) is not relevant to testing a surgical gown's physical properties.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic or decision-making systems.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. The ground truth for this device is established by objective standardized test methods (e.g., AATCC, ASTM, ISO) measuring physical and biological properties.
- The sample size for the training set: Not applicable. This device is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable. This device is not an AI algorithm.
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NOV 1 8 2002
SUMMARY AND CERTIFICATION SRI/SURGICAL EXPRESS, INC., SP™ REUSABLE SURGICAL GOWN
Class II (classification by the General Hospital and Personal use Device Panel)
Common Name: Surgical Gown
ICAL EXPRESS. INC
Classification Name: Surgical Gown
The purpose of this 510(k) submission is to obtain FDA clearance to market a reusable surgical ' gown manufactured with the W.L. Gore ASSIST™ medical fabric in the Critical Zones. The gown in this submission is substantially equivalent to the Sterile Recoveries. Inc. surgical gown as cleared under K920405. The results of safety and efficacy performance testing of the SRI/Surgical Express, Inc. reusable surgical gown as provided in this submission or as referenced in the W.L. Gore Product Master File MAF - 1138 are summarized below. The product is intended to be marketed sterile.
- Biocompatibility: The ASSIST™ medical fabric used in the Critical Zones of this surgical 1. gown complies with the requirements of ISO 10993-1 1997. Acceptable test results were obtained for the washed/dried/sterilized material using the specified test methodology. (Test results can be found in MAF - 1138)
- Flammability: The ASSIST™ medical fabric used in the Critical Zones of this surgical 2. gown complies with the requirements of 16 CFR 1610 Standard for the Flammability of Clothing Textiles (CPSC 1954), Class 1. (Test results can be found in MAF - 1138) The gown also meets requirements of NFPA 99-1999 requlations for non-flammable anesthetizing locations.
- Barrier Performance: The ASSIST™ medical fabric used in the Critical Zones of this 3. surgical gown achieved acceptable results throughout 125 wash/dry/steam autoclave cvcles using the test methods prescribed in AATCC 42-Impact Penetration, and AATCC 127-Water Resistance: Hydrostatic Pressure Test. (Test results can be found in MAF -1138.)
- Physical Properties: The physical properties of ASSIST™ medical fabric were evaluated 4. using various recognized industry standards following 125 wash/dry/steam sterilization cycles. There are currently no limits established for the physical properties evaluated. however conclusions can be drawn to substantiate that the results obtained are comparable to those of currently marketed surgical gowns. Testing was conducted using the following standards: Spray Test, ASTM D3776-96 Standard Test method for mass per unit area (weight) of fabric, ASTM D5035-95 Standard Test Method for breaking force and elongation of textile fabrics (strip break), ASTM D5587-96 Standard test methods for water vapor transmission of materials, and IES-RP-CC003.3-93 Garment system considerations for cleanrooms and other controlled environments - Helmke drum test for garment particulation. (Test results can be found in MAF - 1138)
STERILE RECOVERIES, INC
12425 RACE TRACK ROAD
TAMPA, FL 33626
TEL 813-891-9550
FAX 813-925-8388
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- Sterilization: The gown in this submission has been validated to meet a Sterility દ. Assurance Level of 10 using ANSI/AAMI/ISO 11134:1993 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization.
- Care and Handling: The gown in this submission shall be processed in accordance with 6. the requirements of ANSI/AAMI ST65: 2000 Processing of surgical textiles for use in health care facilities, the care and handling instructions from the manufacturer of the ASSIST™ medical fabric, and SRI/Surgical Express' internal quality system procedures to assure the safety and efficacy of the delivered product. No user instructions related to reprocessing the gown are required since the end-users are advised to return all soiled linen to SRI/Surgical Express, Inc. for reprocessing and sterilization.
Signature of Certifier:
Typed Name: Jack Hamilton
Date: 10/22/02
Title: VP, Product & Process Engineering
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH" around the top and "SERVICES USA" around the bottom. Inside the circle is a stylized image of a human figure with outstretched arms. The figure is made up of three curved lines that represent the head, body, and legs. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
NOV 18 2002
9200 Corporate Boulevard Rockville MD 20850
Mr. Jack A. Hamilton VP. Product & Process Engineering SRI/Surgical Express, Incorporated 12425 Race Track Road Tampa, Florida 33626
Re: K023635
Trade/Device Name: SRI/Surgical Express SP™ Reusable Surgical Gown Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: October 22, 2002 Received: October 29, 2002
Dear Mr. Hamilton:
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 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 – Mr. Hamilton
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Patricia Cucentoffer
Timothy A. Ulatowski 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 STATEMENT
Applicant:
SRI/Surgical Express, Inc.
510(k) Number:
023635
Device Name:
SRI/Surgical Express SP™ Reusable Surgical Gown
Indications for Use:
Surgical gowns are devices that are intended to be worn by health care personnel during surgical or other Ourgiour gowns are a vice that and the wearer from transfer of microorganisms, body fluids, and particulate material.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON AÑOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 Over the Counter _ Yes
Scanned for Clari
vision Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number_
§ 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.