(517 days)
The Bodygard SFS Surgical Gown Level 3 is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification.
The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in four different sizes (M, L, XL, and XXL).
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Bodygard SFS Surgical Gown Level 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile.
The provided document is limited to a 510(k) summary for a surgical gown (Bodygard SFS Surgical Gown Level 3). It details non-clinical performance and substantial equivalence to a predicate device, but it does not contain information on clinical studies, AI algorithms, or human reader performance. Therefore, I cannot answer questions related to those topics.
Here's a breakdown of what can be extracted from the document regarding acceptance criteria and non-clinical studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| AATCC 127 (Water resistance Hydrostatic Pressure) | >50cmH2O (AQL 4%, RQL=20%) | All were > 50cmH2O |
| AATCC 42 (Water Resistance impact penetration) | <1.0 g penetration (AQL 4%, RQL=20%) | All were < 1 g penetration |
| ASTM D 5034-09 (Breaking Strength) | >30 N (AQL 4%, RQL=20%) | All were >30N |
| ASTM D5587-14 (Tearing Strength) | >20 N (AQL 4%, RQL=20%) | All were >20 N |
| 16 CFR 1610 (Flammability testing) | Class I | Meets Class I |
| ASTM D4169-16 (Seam Strength) | >50 N (AQL 4%, RQL=20%) | All were >50 N |
| D6701-16 (Water vapor transmission of Nonwoven and plastic Barriers) | >500 gram/m2 Day WVTR | Passed |
| ASTM D3776/D (Mass Per Area (Weight) of fabric) | - | Has met acceptance criteria |
| ASTM F1670 (Resistance by synthetic Blood) | No Penetration at 2 psi (13.8 kPA) | Passed |
| ISO 9073-10:2003 (Lint and Other particles generation in the dry state) | Log 10<4 | Below Log10<4 Passed |
| ASTM D4169-16 (Performance testing of shipping containers and systems) | Products must withstand the distribution environment | Passed |
| ASTM F88-07A (Seal strength of Flexible Barrier Materials) | Package Seal integrity must be intact. | Passed |
| ASTM F2096-04 (Detecting Gross Leaks in medical packaging by in-ternal pressurization (Bubble test)) | Package integrity must be intact with- out failed seal locations. | Passed |
| ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems for medical devices) | Package integrity must be intact after accelerated aging | Passed |
| ISO 10993-5 (Biological Evaluation of medical devices - Part 5: tests for In vitro cytotoxicity of medical devices) | Device must not be cytotoxic | Device is noncytotoxic |
| ISO 10993-10 (Biological Evaluation of medical devices — Part 10: Tests for irritation and skin sensitization / Irritation) | Device must not be irritant | Device is not an irritant |
| ISO 10993-10 (Biological Evaluation of medical devices — Part 10: Tests for irritation and skin sensitization / sensitization) | Device must not be sensitizer | Device is not a sensitizer |
| ISO 10993-7 (Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals) | Residual Ethylene oxide levels must be below limits | Ethylene Oxide residual levels are below limitations |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test. The acceptance criteria for many tests mention "AQL 4%, RQL=20%", which refers to Acceptance Quality Limit and Rejection Quality Limit, indicating a statistically driven sampling plan, but the specific number of units tested is not provided.
The data provenance is from non-clinical laboratory tests conducted for the purpose of demonstrating device performance against established standards for surgical gowns. No details about country of origin of data are provided beyond the manufacturer and contact person being in Turkey and Virginia, respectively. All tests appear to be prospective as they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The product is a physical medical device (surgical gown), not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" for these tests are the objective measurements and pass/fail criteria of the specified ASTM, AATCC, ISO, and CFR standards.
4. Adjudication method for the test set
This question is not applicable. There is no expert review or adjudication process described for these non-clinical physical and chemical tests. The results are typically objectively measured against the specified acceptance criteria.
5. 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
This question is not applicable. The document describes a physical medical device (surgical gown), not an AI-powered diagnostic or assistive technology. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable, as the device is a physical surgical gown and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests are the established international and national standards and test methods (e.g., AATCC, ASTM, ISO, CFR) for the performance and safety of surgical apparel. These standards define objective pass/fail criteria based on physical, chemical, and biological properties.
8. The sample size for the training set
This question is not applicable. The device is a physical product and does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for a physical surgical gown.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 24, 2022
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi % Darren Reeves President DP Distribution & Consulting, LLC 12240 Hunting Horn Lane Rockville, Virginia 23146
Re: K202845
Trade/Device Name: Bodygard SFS Surgical Gown Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 8, 2022 Received: February 8, 2022
Dear Darren Reeves:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202845
Device Name BodyGard SFS Surgical Gown Level 3
Indications for Use (Describe)
The Bodygard SFS Surgical Gown Level 3 is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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510(k) Summary-K202845 Traditional 510(k)
In accordance with 21 CFR §807.92 and the following information is provided for the Bodygard SFS Surgical Gown Level 3 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Feliks Plastik Lam Ve Amb Mal San Ve Tic LTD StiEskishir Organize Sanayi Bolgesi 26. Cad No. 9 26110Eskisehir |
|---|---|
| Contact Person/Prepared by: | Darren ReevesPresidentDP Distribution & Consulting, LLC(804) 307-7706dreeves@dpdconline.com7305 Hancock Village DriveSuite 109Chesterfield, Virginia 23832 |
| Date: | 02/17/2022 |
| Subject Device: | Trade Name: Bodygard SFS Surgical Gown Level 3Common Name: Surgical GownClassification Name: Surgical Gown (21 CFR 878.4040Product Code FYA) |
| Predicate Device: | Medical Surgical Gowns (K202844) |
Purpose and Device Description:
The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in four different sizes (M, L, XL, and XXL).
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The
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Bodygard SFS Surgical Gown Level 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile.
Intended Use and Indication for Use:
The Bodygard SFS Surgical Gown Level 3 is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification.
Technological Characteristic Comparison of Predicate Device:
| Elements ofComparison | Proposed DeviceK202845 | Predicate DeviceK202844 | Comparison |
|---|---|---|---|
| Bodygard SFS SurgicalGown Level 3 | Medical Surgical Gowns | ||
| 510 (k)Number | K202845 | K202844 | N/A |
| Product Code | FYA | FYA | Same |
| RegulationNumber | 878.4040 | 878.4040 | Same |
| Indication for Use | The Bodygard SFSSurgical Gown Level 3 isa poly reinforcedsurgical gown, SMSNonwoven/Film/SMSNonwoven (SFS) thatprovides AAMI Level 3liquid barrier protectionin the critical zones(arms and chest) andnon-critical zones of thegown. The Bodygard SFSSurgical Gown Level 3 ismanufactured usingultrasonicbonding technique | The Medical SurgicalGowns is intended to beworn by operating roompersonnel during surgicalprocedure to protectboth the surgical patientand the operating roompersonnel from trans- ferof microorganisms, bodyfluids, and particulatematerial.Per ANSI/AAMIPB70:2012Liquid barrierperformance and | Similar |
| and are available infour different sizes(M, L, XL, and XXL).Per ANSI/AAMIPB70:2012 Liquid barrierperformance andclassification ofprotective apparel anddrapes intended for usein health care facilities.The Bodygard SFSSurgical Gown Level 3,meets the requirementsfor Level 3 classification,are disposable medicaldevices and provided insterile. | classification ofprotective appareland drapes intendedfor use inhealth care facilities,the MedicalSurgical Gowns met therequirements for Level3 classification. | ||
| Style | Poly Reinforced | Poly reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Material | Spundbond SMSpolypropylene,polyester, PP Velcro | SMS Nonwoven,polyethylene | Similar |
| Weight perquote | 60 g/m2 | 55 g/m2 | Similar |
| Size | M, L, XL, and XXL | S, M, L, XL, XXL, XXXL | Similar |
| Break Strength | >30N | >20N | Similar |
| Tear Strength | >20N | >20N | Similar |
| Seam Strength | > 50 N | Not known | Similar |
| lint | Log10<4 | Log10<4 | Same |
| Flammability | Class I | Class I | Same |
| Hydrostaticpressure | >50cm | >50cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Level | Level 3 Per AAMI PB70 | Level 3 per AAMI PB70 | Same |
| Water Vapor Transmission | Averagetransmission/permeatio nrate 4.360 gm/m2 day | Unknown | Unknown |
| Elements of Comparison | Proposed Device | Predicate Device | Remark |
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Skin Irritation | No Irritation | No Irritation | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Sterile | Ethylene Oxide (EO),SAL=10-6 | Ethylene Oxide (EO),SAL=10-6 | Same |
Table 1 Technological Characteristic Comparison
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Summary of Non-Clinical Test:
Non-Clinical Tests:
The product was tested in alignment with "Guidance on Premarket Notification 510(k) Submissions for Surgical Gowns and Surgical" Guidance Document
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 127 | Water resistanceHydrostatic Pressure | >50cmH2O (AQL 4%,RQL=20%) | All were > 50cmH2O |
| AATCC 42 | Water Resistance impactpenetration | <1.0 g penetration(AQL 4%, RQL=20%) | All were < 1 gpenetration |
| ASTM D 5034-09 | BreakingStrength | >30 N (AQL 4%,RQL=20%) | All were >30N |
| ASTM D5587- 14 | Tearing Strength | >20 N (AQL 4%,RQL=20%) | All were >20 N |
| 16 CFR 1610 | Flammabilitytesting | Class I | Meets Class I |
| ASTM D4169- 16 | Seam Strength | >50 N (AQL 4%,RQL=20%) | All were>50 N |
| D6701-16 | Water vaportransmission of | >500gram/m2 DayWVTR | Passed |
| Nonwoven andplastic Barriers | |||
| ASTM D3776/D | Mass Per Area (Weight)of fabric | - | Has met acceptancecriteria |
| ASTM F1670 | Resistance by syntheticBlood | No Penetration at 2 psi(13.8 kPA) | Passed |
| ISO 9073-10:2003 | Lint and Other particlesgeneration in the drystate | Log 10<4 | Below Log10<4 Passed |
| ASTM D4169- 16 | Performance testing ofshipping containersand systems | Products must with-stand the distributionenvironment | Passed |
| ASTM F88-07A | Seal strength ofFlexible BarrierMaterials | Package Seal integritymust be intact. | Passed |
| ASTM F2096- 04 | Detecting Gross Leaks inmedical packaging by in-ternal pressurization(Bubble test) | Package integrity mustbe intact with- out failedseal locations. | Passed |
| ASTM F1980- 07 | Accelerated Aging ofSterile Barrier Systems formedical devices | Package integrity mustbe intact afteraccelerated aging | Passed |
| ISO 10993-5 | Biological Evaluation ofmedical devices - Part 5 :tests for In vitrocytotoxicity ofmedical devices | Device must not becytotoxic | Device is noncytotoxic |
| ISO 10993-10 | Biological Evaluation ofmedical devices — Part10: Tests for irritationand skinsensitization / Irritation | Device must not beirritant | Device is not an irritant |
| ISO 10993-10 | Biological Evaluation ofmedicaldevices — Part | Device must not besensitizer | Device is not asensitizer |
| 10: Tests for irritationand skin sensitization /sensitization | |||
| ISO 10993-7 | Biological Evaluation ofmedical devices- Part 7:Ethylene OxideSterilization Residuals | Residual Ethylene oxidelevels must be belowlimits | Ethylene Oxide residuallevels are belowlimitations |
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Summary of Clinical Tests:
No clinical tests were performed.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the device Bodygard SFS Surgical Gown Level 3 is as safe, as effective, and performs as well as or better than the legally marketed predicate device Medical Surgical Gowns.
§ 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.