(172 days)
Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.
Disposable Gowns manufactured from non-woven fabric. Various sizes and materials.
The provided document is a 510(k) Summary for a medical device, specifically surgical gowns. It outlines the device's classification, intended use, and comparison to predicate devices, along with a summary of performance data. However, this document does not describe a study involving an AI/Machine Learning (ML) device or its acceptance criteria.
The "device" in question is a physical medical device (surgical gowns), not an AI/ML algorithm. The performance data listed (flammability, lint, tensile strength, water resistance, etc.) are standard physical and material property tests for surgical gowns, not metrics typically associated with AI/ML performance like sensitivity, specificity, or AUC.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, the study proving its adherence to those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, because the submitted document pertains to a traditional medical device and not an AI/ML device.
The document details the following for the surgical gowns:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present "acceptance criteria" in a pass/fail format within a single table. Instead, it lists various "Performance Testing" and "Performance Standards Used" which imply the criteria that the gowns must meet. The "Data Generated" column for each standard indicates the type of performance evaluated. The implicit acceptance criterion for this type of medical device (surgical gowns) is that they meet the specified performance standards for properties like water resistance, tensile strength, flammability, and biocompatibility, demonstrating substantial equivalence to predicate devices.
| Standard or Guidance Document | Data Generated |
|---|---|
| AAMI/ANSI/ISO 11135-1 2007 (Ethylene Oxide Sterilization) | EtO Sterilization Parameters |
| AAMI / ANSI / ISO 10993-7:1995 (EO Residual Determination) | EO Residuals |
| AAMI / ANSI / ISO 10993-1:2003(E) (Biological evaluation of medical devices) | Biocompatibility Testing Evaluation |
| AAMI / ANSI / ISO 10993-5: (1999 and 2009) (In Vitro cytotoxicity) | Cytotoxicity |
| AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006 (Irritation and sensitization) | Skin Irritation, intra-cutaneous reactivity & sensitization |
| AATCC Test Method 127-2008 (Water Resistance: Hydrostatic Pressure Test) | Hydrostatic Pressure - Water Resistance |
| AATCC Test Method 42-2007 (Water Resistance: Spray Impact Penetration Test) | Impact Penetration - Water Resistance |
| ASTM - D5034-2008 (Breaking Strength and Elongation of Textile Fabrics) | Tensile Strength |
| ASTM -- D5734-1995(2001) (Tearing Strength of Nonwoven Fabrics by Falling-Pendulum (Elmendorf) Apparatus) | Elmendorf Tear |
| ISO 9073-10:2003 (Textiles -- Test methods for nonwovens -- Part 10: Lint and other particles generation in the dry state) | Gelbo Flex - Lint |
| CPSC 16 CFR 1610-2004 (Standard for Flammability of Clothing Textiles) | Flammability |
Points 2-9 are not applicable as the document describes a physical medical device (surgical gowns), not an AI/ML device.
The document states, "The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and testing methods." This indicates that the study involved performing tests according to the listed standards and comparing the results to those expected for predicate devices to establish substantial equivalence.
This submission is a 510(k) premarket notification for traditional medical devices (surgical gowns), which does not involve AI or machine learning. Therefore, the requested information related to AI/ML device performance, such as sample sizes for test/training sets, expert qualifications for ground truth establishment, adjudication methods, or MRMC studies, is not present or relevant in this document.
{0}------------------------------------------------
0 097 /
==
510(k) Summary Section 5:
1.0 Submitted By:
SEP 27 2010
Gary Zhu, President
Hangzhou ATek Medical and Textile Co. Ltd.
Suite No. 503
Xi Xia Yuan No. 514
Hangzhou 310006
Zhe Chiang Province, China
Establishment Registration Number: 9615944
Primary Contact:
Glen Feye, President
Accurate Consultants, Inc. ·
1340 West Pennsylvania Ave.
San Diego, CA 92103
Telephone: 619-291-3695/ Fax: 619-393-0582
glen@accuratefdaconsulting.com
September 22, 2010 2.0 Date Submitted:
3.0 Device Name(s):
- Proprietary Names 3.1
{1}------------------------------------------------
| MATERIAL | GOWN STYLE | STERILE/NON | Sizes | Model number |
|---|---|---|---|---|
| SMS | Reinforced | Non Sterile | L/XL/XXL | AKSG74100 |
| Reinforced | Sterile | L/XL/XXL | AKSG74700 | |
| Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG78100 | |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG78700 | |
| HYDRO-ENTANGLED(Spunlance) | Non-reinforced | Non Sterile | L/XL/XXL | AKSG80100 |
| Non-reinforced | Sterile | L/XL/XXL | AKSG80700 | |
| Non-reinforcedwith guider | Non Sterile | L/XL/XXL | AKSG82100 | |
| Non-reinforcedwith guider | Sterile | L/XL/XXL | AKSG82700 | |
| Reinforced | Non Sterile | L/XL/XXL | AKSG84100 | |
| Reinforced | Sterile | L/XL/XXL | AKSG84700 | |
| Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG88100 | |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG88700 | |
| SFT | Reinforced | Non Sterile | L/XL/XXL | AKSG94100 |
| Reinforced | Sterile | L/XL/XXL | AKSG94700 | |
| Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG98100 | |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG98700 |
Hangzhou ATek Medical &Textile Surgical Gowns, Various
Common Name 3.2
Surgical Gown
Product code - FYA (Gown, Surgical)
3.3 Classification Name
{2}------------------------------------------------
Gown, Surgical (21CFR 878.4040 Product code - FYA )
4.0 Predicate Devices:
| Candidate | Predicate | Manufacturer | Docket Number |
|---|---|---|---|
| Hangzhou ATekMedical andTextile SurgicalGowns | IMC SurgicalGowns | International MedsurgConnections, Inc. | K052550 |
| Master & FrankSurgical Gowns(Sterile) | Master and FrankEnterprises, Co. LTD | K012186 |
5.0 Intended Use:
Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.
The following disposable surgical gown types and model numbers are included in this submission
{3}------------------------------------------------
| MATERIAL | GOWN STYLE | STERILE/NON | Sizes | Model number |
|---|---|---|---|---|
| SMS | Reinforced | Non Sterile | L/XL/XXL | AKSG74100 |
| Reinforced | Sterile | L/XL/XXL | AKSG74700 | |
| Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG78100 | |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG78700 | |
| HYDRO-ENTANGLED(Spunlance) | Non-reinforced | Non Sterile | L/XL/XXL | AKSG80100 |
| Non-reinforced | Sterile | L/XL/XXL | AKSG80700 | |
| Non-reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG82100 | |
| Non-reinforcedwith Guider | Sterile | L/XL/XXL | AKSG82700 | |
| Reinforced | Non Sterile | L/XL/XXL | AKSG84100 | |
| Reinforced | Sterile | L/XL/XXL | AKSG84700 | |
| SFT | Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG88100 |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG88700 | |
| Reinforced | Non Sterile | L/XL/XXL | AKSG94100 | |
| Reinforced | Sterile | L/XL/XXL | AKSG94700 | |
| Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG98100 | |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG98700 |
6.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.
{4}------------------------------------------------
| Aspect/Characteristic | Predicate Gowns | IMC GownsK052550 | Master Frank GownsK012186 |
|---|---|---|---|
| Indications ForUse | Disposable gowns areworn by operating roompersonnel duringsurgical procedures toprotect both thesurgical patient and ORpersonnel from thetransfer of body fluidsand particulatematerial.Gowns provided assterile and non-sterile. | Surgical Gown isintended to be usedas patientprotectivecoverings used toisolate incision sitesand protect againstcontaminationduring surgicalprocedures.Gowns provided assterile and non-sterile | Single Use article ofsurgical apparel wornby operator roompersonnel duringsurgical procedures toprotect both thesurgical patient andthe operating roompersonnel fromtransfer ofmicroorganisms, bodyfluids, particulatematerial.Sterile SurgicalGowns only |
| Class | 2 | 2 | 2 |
| Product Code | FYA | FYA | FYA |
| DeviceDescription | Disposable Gownsmanufactured from non-woven fabric. Varioussizes and materials. | Disposable Gownsmanufactured fromnon-woven fabric.Various sizes andmaterials. | Disposable Gownsmanufactured fromnon-woven fabric.Various sizes andmaterials. |
| Model Numbers | Various | Various | Various |
| MaterialCharacteristics | SMS/Hydro-Entangled(Spunlace), SFT | Multiple SMS andSPP (Spunlace) | SFT |
| PerformanceTesting | Flammability- CPSC 16CFR 1610Lint ISO 9073-10:2003Tensile Strength- ASTMD5034 | Flammability-CPSC 16 CFR 1610Lint ISO 9073-10:2003Tensile Strength-ASTM D5034 | Flammability- 16 CFRPart 10Lint IST 160.1Tensile Strength-ASTM D5034 |
| PerformanceStandards Used | AATCC 127AATCC 42 | AATCC 127AATCC 42 | AATCC 127AATCC 42 |
| BiocompatibilityStandards Used | ISO 10933-5ISO 10933-10 | ISO 10933-5ISO 10933-10 | ISO 10933-5ISO 10933-10ISO 10933-11 |
.
:
,
·
.
.
.
ﺗ
:
{5}------------------------------------------------
7.0 Summary of Performance Data:
The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial Equivalence is demonstrated through intended use, materials, distribution. design and testing methods.
| Standard or Guidance Document | Data Generated | RelevantSection ofSubmission |
|---|---|---|
| AAMI/ANSI/ISO 11135-1 2007, MedicalDevices -Validation and Routine Control ofEthylene OxideSterilization | EtO SterlizationValidationParameters | 14 |
| AAMI / ANSI / ISO 10993-7:1995, Biologicalevaluation of medical devices -- Part 7: EOResidual Determination | EO Residuals | 14 |
| AAMI / ANSI / ISO 10993-1:2003(E),Biological evaluation of medical devices --Part 1: Evaluation and testing | BiocompatibilityTesting Evaluation | 15 |
| AAMI / ANSI / ISO 10993-5: (1999 and2009) Biological evaluation of medicaldevices -- Part 5: Tests for In Vitrocytotoxicity | Cytotoxicity | 15 |
| AAMI / ANSI / ISO 10993-10:2002/Amd.1:2006, Biological evaluation of medicaldevices -- Part 10: Tests for irritation andsensitization | Skin Irritation, intra-cutaneousreactivity &sensitization | 15 |
| AATCC Test Method 127-2008Water Resistance: Hydrostatic PressureTest | HydrostaticPressure - WaterResistance | 18 |
| AATCC Test Method 42-2007Water Resistance: Spray ImpactPenetration Test | Impact Penetration- Water Resistance | 18 |
| ASTM - D5034-2008 Standard Test Methodfor Breaking Strength and Elongation ofTextile Fabrics (Grab Test) | Tensile Strength | 18 |
Test Data Provided in this Submission
{6}------------------------------------------------
| Standard or Guidance Document | Data Generated | RelevantSection ofSubmission |
|---|---|---|
| ASTM -- D5734-1995(2001) Standard TestMethod for Tearing Strength of NonwovenFabrics by Falling-Pendulum (Elmendorf)Apparatus | Elmendorf Tear | 18 |
| ISO 9073-10:2003 - Textiles -- Testmethods for nonwovens -- Part 10: Lint andother particles generation in the dry state | Gelbo Flex - Lint | 18 |
| CPSC 16 CFR 1610-2004 Standard forFlammability of Clothing Textiles | Flammability | 18 |
:
:
:---
{7}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. The overall design is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hangzhou Atek Medical & Textile Company, Limited C/O Mr. Glen Feye Accurate Consultants Incorporated 1340 West Pennsylvania Avenue San Diego, California 92103
SEP 2 7 2010
Re: K100971
Trade/Device Name: Hangzhou ATek Medical & Textile Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: September 10, 2010 Received: September 13, 2010
Dear Mr. Feye:
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.
{8}------------------------------------------------
Page 2- Mr. Feye
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/CDRHQffices/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 yours,
for
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
{9}------------------------------------------------
ATTACHAGA
K110971 Section 4: Indications for Use Statements
Indications for Use
SEP 27 2010
510(k) Number (if known): K100971
Device Name: Hangzhou ATek Medical &Textile Surgical Gowns
Indications for Use:
Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.
The following disposable surgical gown types and model numbers are included in this submission
{10}------------------------------------------------
| MATERIAL | GOWN STYLE | STERILE/NON | Sizes | Model number |
|---|---|---|---|---|
| SMS | Reinforced | Non Sterile | L/XL/XXL | AKSG74100 |
| Reinforced | Sterile | L/XL/XXL | AKSG74700 | |
| Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG78100 | |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG78700 | |
| HYDRO-ENTANGLED(Spunlance) | Non-reinforced | Non Sterile | L/XL/XXL | AKSG80100 |
| Non-reinforced | Sterile | L/XL/XXL | AKSG80700 | |
| Non-reinforcedwith guider | Non Sterile | L/XL/XXL | AKSG82100 | |
| Non-reinforcedwith guider | Sterile | L/XL/XXL | AKSG82700 | |
| Reinforced | Non Sterile | L/XL/XXL | AKSG84100 | |
| Reinforced | Sterile | L/XL/XXL | AKSG84700 | |
| Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG88100 | |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG88700 | |
| SFT | Reinforced | Non Sterile | L/XL/XXL | AKSG94100 |
| Reinforced | Sterile | L/XL/XXL | AKSG94700 | |
| Reinforcedwith Guider | Non Sterile | L/XL/XXL | AKSG98100 | |
| Reinforcedwith Guider | Sterile | L/XL/XXL | AKSG98700 |
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)
Elizabeth F. Clarence-Williams
(Division Sign-Off) (Division of Anesthesiology, General Hospital
Infection of Anesthesiology, General Devices
510(k) Number: K 1 O O 9 21 --------------------------------------------------------------------------------------------------------------------------------------------------
§ 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.