(148 days)
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.
The document is a 510(k) Premarket Notification from the FDA regarding a Disposable Surgical Gown. It outlines the device's technical specifications and compares it to a predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and safety testing required for regulatory clearance, not studies involving AI or human reader performance as one might expect for a diagnostic AI device.
Here's an analysis based on the provided document:
This document describes the testing for a Disposable Surgical Gown, which is a physical medical device, not a diagnostic AI/algorithm. Therefore, concepts like "MRMC comparative effectiveness study," "standalone algorithm performance," "human readers improve with AI," "number of experts for ground truth," "adjudication method," and "training set size/ground truth establishment" are not applicable to this type of medical device submission. The "acceptance criteria" relate to physical and biological performance characteristics of the gown.
Non-Clinical Performance and Safety Testing for Disposable Surgical Gown
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Test Methodology Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AAMI/ANSI PB70:2012 (Liquid Barrier) | Determine classification of subject surgical gown product. | N/A (classification level) | PASS (Level 3) |
| ASTM D5587-15 (Tearing Strength) | Evaluate tearing strength. | >30N | PASS (72/59N average from 3 nonconsecutive batches) |
| ASTM D5034-21 (Breaking Strength) | Evaluate breaking strength. | >10N | PASS (99/81N average from 3 nonconsecutive batches) |
| ASTM D1683M-17 (Seam Strength) | Evaluate failure in sewn seams. | >30N | PASS (Sleeve: 68.3N, Side: 69.7N, Belt: 71N average from 3 nonconsecutive batches) |
| AATCC 42-2013 (Water Impact) | Evaluate water impact. | ≤1.0 g | PASS (0~0.019 g average from 3 nonconsecutive batches) |
| ASTM F1868-17 (Evaporative Resistance) | Evaluate evaporative resistance. | < 3 Pa.m²/W. | PASS (2.46 Pa.m²/W. average from 3 nonconsecutive batches) |
| AATCC 127-2014 (Hydrostatic Pressure) | Determine hydrostatic pressure. | >50 cm | PASS (52~290 cm average from 3 nonconsecutive batches) |
| CPSC 16 CFR Part 1610-2008 (Flammability) | Evaluate flammability. | Meets Class I requirements | PASS (Class I average from 3 nonconsecutive batches) |
| ISO 9073-10:2003(E) (Linting) | Evaluate lint and other particles generation. | Log10(particle count) < 4 | PASS (3.0 average from 3 nonconsecutive batches) |
| ISO 10993-10:2010 (Irritation/Sensitization) | Demonstrate biocompatibility. | Non-irritating, Non-sensitizing | PASS (Non-irritating, Non-sensitizing) |
| ISO 10993-5:2009 (Cytotoxicity) | Demonstrate biocompatibility. | Non-cytotoxic | PASS (Non-cytotoxic) |
2. Sample size used for the test set and the data provenance:
The document states that results are "Average result from 3 nonconsecutive batches" for several tests (Tearing Strength, Breaking Strength, Seam Strength, Water Impact, Evaporative Resistance, Hydrostatic Pressure, Flammability, Linting). The specific number of gowns or material samples per batch is not explicitly stated but implies a representative sample was taken from different production runs.
- Provenance: "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The manufacturer is Suzhou JaneE Medical Technology Co., Ltd. in China, implying testing was conducted or overseen by them or a contracted lab. The document does not specify if the data is retrospective or prospective, but for manufacturing quality control and regulatory submission, it would typically be prospective testing on newly produced batches.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This pertains to an AI/diagnostic device. For a physical device like a surgical gown, "ground truth" is established by adherence to recognized international standards and laboratory testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This pertains to an AI/diagnostic device and human reader disagreement. Physical testing relies on standardized methodologies and calibrated equipment.
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:
Not applicable. This relates to AI-assisted diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This relates to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on established international and national standards and test methodologies for material properties and barrier performance (e.g., AAMI PB70, ASTM, AATCC, ISO, CPSC). Compliance with these quantitative and qualitative standards serves as the benchmark for acceptance. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO 10993 standards.
8. The sample size for the training set:
Not applicable. This product is a physical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This product is a physical device, not an AI algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 11, 2022
Suzhou JaneE Medical Technology Co., Ltd % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14 th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K212591
Trade/Device Name: Disposable Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 8, 2021 Received: December 8, 2021
Dear Ivy Wang:
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 mediation-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,
For 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) K212591
Device Name Disposable Surgical Gown
Indications for Use (Describe)
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary K212591
A. Applicant:
Suzhou JaneE Medical Technology Co., Ltd. Address: No.339 HuaFeng Road, New District, Suzhou, Jiangsu Province, China, 215129 Contact person: Mr. Zhu Li Tel: +86 13951116714 Email: zhuli@sz-dk.cn
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050
Email: fda.sungo@gmail.com
B. Device:
Trade Name: Disposable Surgical Gown Common Name: Surgical Gown Model(s): Reinforced
Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K170762 Cardinal Health™ Non-Reinforced Surgical Gown Cardinal Health 200, LLC
D. Intended use of the device:
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical
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Suzhou JaneE Medical Technology Co., Ltd. No.339 HuaFeng Road, New District, Suzhou, Jiangsu Province, China, 215129
procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
E. Device Description:
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | Suzhou JaneE MedicalTechnology Co., Ltd. | Cardinal Health™ | - |
| 510K number | K212591 | K170762 | - |
| Product Name | Disposable Surgical Gown | Cardinal Health™ Non-Reinforced Surgical Gown | - |
| Classification | Class II Device, FYA (21CFR878.4040) | Class II Device, FYA (21CFR878.4040) | Same |
| Intended Use | The Disposable SurgicalGowns are intended to beworn by operating roompersonnel during surgicalprocedures to protect thesurgical patient andoperating room personnelfrom the transfer ofmicroorganisms, bodyfluids and particulatematter. In addition, thissurgical gown meets therequirements of AAMILevel 3 barrier protectionfor a surgical gown perANSI/AAMI PB70:2012Liquid barrierperformance andclassification ofprotective apparel anddrapes intended for use inhealth care facilities | Cardinal Health™ Non-Reinforced Surgical Gown isintended to be worn byoperating room personnelduring surgical procedures toprotect the surgical patient andoperating room personnel fromthe transfer of microorganisms,body fluids and particulatematerial. In addition, thissurgical gown meets therequirements of AAMI Level 3barrier protection for a surgicalgown per ANSI/AAMIPB70:2012 Liquid barrierperformance and classificationof protective apparel and drapesintended for use in health carefacilities (AAMI PB70). TheCardinal Health™ Non-Reinforced Surgical Gowns aresingle use, disposable medical | Same |
| (AAMI PB70). This is asingle use, disposabledevice, provided sterile. | devices; provided sterile andnon-sterile. | ||
| MaterialComposition | Polyolefin(Polypropylene) SMSnonwoven | Polyolefin (Polypropylene)SMS nonwoven | Same |
| Sterility | Sterile | Sterile and non-sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | Blue | Same |
| Size | M,L,XL,TL | M-S, M, L, XL, XXL | Similar. Noeffect onsafety orefficacy |
| Weight persquare(g) | Critical Area: 87.8g/m²Non-Critical Area:45.12g/m² | 31g/m² (1.32 oz/yd²) | Similar. Noeffect onsafety orefficacy.Both passedperformancetests. |
| Tensile | MD: 16.18 lbs (72N) CD:13.26 lbs (59N) | MD Mean 21.57 lbs CD Mean13.6 lbs | Similar. Noeffect onsafety orefficacy.Both passedperformancetests. |
| Tear | MD:22.25 lbs (99 N)CD:18.20 lbs (81N) | MD Mean 3.47 lbs CD Mean5.63 lbs | Similar. Noeffect onsafety orefficacy.Both passedperformancetests. |
| Seam Strength | Sleeve Seam:68.3NSide Seam:69.7NBelt Seam:71N | No available | Similar. Noeffect onsafety orefficacy.Both passedperformancetests. |
| HydrostaticPressure(cm)AATCC-127 | >50 cm | >50 cm | Same |
| Water Impact (g)AATCC-42 | ≤1.0 g | ≤1.0 g | Same |
| Resistance toblood and liquidpenetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same |
| Biocompatibility | Under the conditions of the study, the device extract was not cytotoxic.Under the conditions of the study, the non-polar and polar device extracts were not found to be an irritant.Under conditions of the study, the non-polar and polar device extracts were not found to be a sensitizer. | Same |
F. Comparison with predicate device
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Suzhou JaneE Medical Technology Co., Ltd. No.339 HuaFeng Road, New District, Suzhou, Jiangsu Province, China, 215129
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G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.
| Test Methodology | Test MethodologyPurpose | Acceptance Criteria | Results |
|---|---|---|---|
| AAMI/ANSIPB70:2012, LiquidBarrier Performanceand Classification ofprotective Apparel andDrapes Intended ForUse In Health CareFacilities. | The tests wereperformed to determinethe classification ofsubject surgical gownproduct. | N/A | Level 3 |
| ASTM D5587-15,Standard Test Methodfor Tearing Strength ofFabrics by TrapezoidProcedure | The test was performedin accordance withASTM D5587:2015(2019) StandardTest Method forTearing Strength ofFabrics by TrapezoidProcedure to evaluatethe tearing strength ofthe test sample. | >30N | PASS72/59N(Average result from 3nonconsecutive batches) |
| ASTM D5034-21,Standard Test Methodfor Breaking Strengthand Elongation ofTextile Fabrics (GrabTest) | The test was performedIn accordance withASTM D5034-21.Standard. Test Methodfor Breaking Strengthand Elongation ofTextile Fabrics (GrabTest) to evaluate thebreaking strength of thetest sample. | >10N | PASS99/81N(Average result from 3nonconsecutive batches) |
| ASTM D1683M-17Standard Test Methodfor Failure in SewnSeams of WovenFabrics. | The test was performedIn accordance withASTM D1683M-17Standard. Test Methodfor Seam Strength ofTextile Fabrics (GrabTest) to evaluateFailure in Sewn Seamsof the test sample. | >30N | PASSSleeve Seam:68.3NSide Seam:69.7NBelt Seam:71N(Average result from 3nonconsecutive batches) |
| AATCC 42-2013,Water PenetrationResistance: ImpactPenetration Test; | The test was performedin accordance withAATCC 42: 2013Water Resistance:Impact Penetration Testto evaluate the waterimpact of the testsample. | ≤1.0 g | PASS0~0.019 g(Average result from 3nonconsecutive batches) |
| Evaporative ResistanceASTM F1868-17 | The test was performedin accordance withASTM F1868-17 toevaluate theEvaporative Resistanceof the test samples | < 3 Pa.m²/W. | PASS2.46 Pa.m²/W.(Average result from 3nonconsecutive batches) |
| AATCC 127-2014,Water Resistance:Hydrostatic PressureTest: | The test was performedin accordance withAATCC 127: 2014Water Resistance:Hydrostatic PressureTest to determine thehydrostatic pressure ofthe test sample. | >50 cm | PASS52~290 cm(Average result from 3nonconsecutive batches) |
| CPSC 16 CFR Part1610-2008, Standardfor the Flammability ofclothing textiles | The test was performedin accordance with 16CFR Part 1610Standard for theFlammability ofClothing Textiles toevaluate theflammability of the testsample. | Meets Class Irequirements | PASSClass I(Average result from 3nonconsecutive batches) |
| ISO 9073- 10:2003(E)Lint and Other ParticlesGeneration | The test was performedin accordance with ISO9073-10: 2003 Textiles-Test Methods forNonwovens-Part 10:Lint and Other ParticlesGeneration in the DryState to evaluate thelinting of the testsample. | Log10(particle count) < 4 | PASS3.0(Average result from 3nonconsecutive batches) |
| ISO 10993-10: 2010Biological Evaluationof Medical Devices -Part 10: Tests ForIrritation And SkinSensitization | The purpose of thebiocompatibility testingis to demonstrate thebiocompatibility of thesubject device. | Non-irritating, andNon-sensitizing. | PASSUnder the conditions ofthe study, the device isnon-irritating, and non-sensitizing. |
| ISO 10993-5: 2009Biological Evaluationof Medical Devices --Part 5: Tests For InVitro Cytotoxicity | The purpose of thebiocompatibility testingis to demonstrate thebiocompatibility of thesubject device. | Non-cytotoxic. | PASSUnder the conditions ofthe study, the device isnon-cytotoxic. |
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H. Clinical Test Conclusion
No clinical study is included in this submission.
Conclusion I.
Based on the comparison and analysis above, the subject device, K212591 Disposable Surgical Gown, is as safe, as effective, and performs as well as the legally marketed predicate device, Disposable Surgical Gowns cleared under K170762.
§ 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.