(48 days)
The Convertors® Spunbonded, Flashspun Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Convertors® Spunbonded, Flashspun Polyolefin Gowns, Sterile. Each gown is packaged with a towel.
This document describes a 510(k) submission for Convertors® Spunbonded, Flashspun Polyolefin Gowns. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance metrics. Therefore, a direct response to your request about acceptance criteria and a study proving a device meets them, in the typical sense of a diagnostic or therapeutic device with quantitative outcomes, is not fully applicable.
However, I can extract the relevant information from the provided text regarding how the device's acceptability was established, which can be framed to address aspects of your request where possible.
Here's a breakdown based on the provided text, interpreting "acceptance criteria" and "study" within the context of a 510(k) for surgical gowns:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Intended Use | "The intended use is the same" as the predicate device (Convertors® Optima standard, fabric- and poly-reinforced gowns). |
| Performance Attributes | "The performance attributes are the similar" to the predicate device. |
| Biocompatibility | All materials "evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'." |
| Specific Biocompatibility Tests | Sensitization, cytotoxicity, and irritation/intracutaneous reactivity tests were performed. |
| Industry Recognized Test Methods | Materials "were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." |
| Protection (Implied) | Protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material (same as predicate). |
Note: The document for a surgical gown 510(k) generally focuses on demonstrating substantial equivalence through similar intended use, performance attributes, and material safety rather than a clinical effectiveness study with specific diagnostic accuracy or treatment efficacy endpoints. The "performance attributes" likely refer to properties like barrier effectiveness, fluid resistance, strength, etc., which would have established acceptance ranges but are not explicitly detailed here.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size for "performance attributes." The description states "All materials used in the fabrication of this Convertors® Spunbonded, Flashspun Polyolefin gowns were evaluated..." This implies the materials themselves were the "sample" for biological qualification and other industry-recognized tests.
- Data Provenance: The document does not specify country of origin for the data or whether tests were retrospective or prospective. It only mentions compliance with ISO 10993 Part-1 and "industry recognized test methods."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This type of information (number of experts, qualifications, ground truth establishment) is typically not part of a 510(k) submission for surgical gowns. The "ground truth" here is established via adherence to recognized standards (ISO 10993) and industry-accepted test methods for material properties, rather than expert consensus on clinical outcomes or image interpretations. The "experts" are likely the laboratory personnel performing the standardized biocompatibility and material property tests.
4. Adjudication Method (for the test set)
- Not applicable in the context of this 510(k) submission for a surgical gown. Adjudication methods (like 2+1) are typically used in clinical studies or studies involving expert interpretation (e.g., radiology reads) to resolve discrepancies. The assessment here is based on objective laboratory testing against established material specifications and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or certain therapeutic devices where human readers or clinicians interpret data. Surgical gowns are evaluated for their barrier properties and biocompatibility, not for interpretation-based outcomes.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a physical surgical gown, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for the material evaluation relies on established international standards (ISO 10993 Part-1 for biocompatibility) and industry-recognized test methods for material performance attributes. This includes objective measurements for sensitization, cytotoxicity, irritation/intracutaneous reactivity, and implied physical properties (e.g., barrier effectiveness, durability) that are not detailed in this summary.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI or machine learning model that requires a "training set." The "training" in the context of a 510(k) for a physical device would refer to manufacturing processes and quality control, not data training.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reasons as point 8.
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AUG 2 4 1998
Allegiance
Park, Illinois 60085-678
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Spunbonded, Flashspun Polyolefin Gowns
Intended Use:
Substantial Equivalence:
patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The Convertors® Spunbonded, Flashspun
surgical procedures to protect both the surgical
Surgical apparel are devices intended to be
worn by operating room personnel during
Polyolefin gowns are substantially equivalent to the Convertors® Optima standard, fabric- and poly-reinforced gowns in that:
- the intended use is the same
- the performance attributes are the similar
All materials used in the fabrication of this Convertors® Spunbonded, Flashspun Polyolefin evaluated through biological aowns were qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were sensitization, cvtotoxicity, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Summary of testing:
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XIII. SAMPLE
A drawing of the standard, fabric- and poly-reinforced gowns are enclosed to visually assist with the review. (See Appendix D).
XIV. KIT INFORMATION
Each gown is packaged with a towel. The towel is the same towel that is currently placed in our gown packs. This towel has been used safely and effectively for many years as a component of the gown This premarket notification (510(k)) is to introduce standard, pack. fabric and poly-reinforced gowns constructed of Spunbonded, Flashspun Polyolefin fabric. There is no change to the towel contained within this pack.
XV. 21 CFR 807.95 -CONFIDENTIALITY
Allegiance Healthcare Corporation regards its intent to market the Convertors® Spunbonded, Flashspun Polyolefin gown as confidential commercial information. Allegiance Healthcare Corporation has not divulged this intent to market information to anyone other than Allegiance employees and even then on a need-to-know basis. Therefore, we request that FDA treat this information in a confidential manner.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of a human figure with three arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1998
Ms. Sharon Robbins Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, Illinois 60085-6787
Re : K982369 Convertors® Spunbonded, Flashspun Trade Name: Polyolefin Gowns, Sterile Regulatory Class: II Product Code: FYC Dated: July 1, 1998 Received: July 7, 1998
Dear Ms. Robbins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include reguirements 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Robbins
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
S. Butman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... ......
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Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 7.473.1500 AX: 847.785.2461
Page 1 of 1
510(k) Number (if known):
Device Name:
Convertors® Spunbonded, Flashspun Polyolefin Gowns, Sterile
Indications For Use:
The Convertors® Spunbonded, Flashspun Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) or
Over-The Counter Use
Chim S. f.
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 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.