(86 days)
Medline Disposable Sterile Surgical Gowns, Zoned Impervious are surgical apparel that is intended to be wom 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.
Medline Disposable Sterile Zoned Impervious Surgical Gowns are manufactured from a non-woven fabric which is laminated to a plastic film. Because the plastic film is made of microporous polyethylene, it provides protection from inward liquid penetration as well as comfort by allowing outward passage of vapor. These products are disposable and intended for single use only. The Sontara Spunlace Fabric is produced by DuPont. It is a hydroentangled (or hydrolaced) fabric made using a Spunlace technology. For medical applications, the content is approximately 55% wood pulp and 45% polyester. The interlaced fibers and surface finish give Sontara outstanding barrier properties while providing the comfort features of re-usable linens. This product has seams which are bound to provide strength and barrier properties. Tape is utilized to cover the drill holes required during manufacturing. There are long stockinet cuffs on the sleeves for added comfort and protection. Both Velcro and snaps are offered as closures. The materials used in Medline's gowns are strong, do not unravel or delaminate and are low in lint.
The provided text describes a 510(k) submission for Medline Disposable Sterile Zoned Impervious Surgical Gowns. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive independent clinical study data to prove the performance against a set of acceptance criteria in the way a diagnostic or therapeutic device might.
However, based on the information provided, we can infer acceptance criteria related to material properties and barrier performance. The "study" described is a set of non-clinical tests.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance Study for Medline Disposable Sterile Zoned Impervious Surgical Gowns
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Johnson & Johnson Medical, Inc.'s Barrier Fabric 450 Surgical Gown, K934608). The "acceptance criteria" are implied by the performance characteristics presented in comparison to the predicate, and the regulatory requirements for surgical gowns. The study conducted comprises non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature (Implied Acceptance Criteria) | Standard/Method (if specified) | Predicate Device Performance (Reference) | Medline Device Performance (Reported) | Meets Criteria? |
|---|---|---|---|---|
| Material Composition | - | Non-woven hydroentangled fabric, spunlace technology | Sontara Spunlace – Non-woven hydroentangled fabric, spunlace technology | Yes (Functionally the same) |
| Weight Per Square Yard | - | 2.1 oz/yd² | 1.70 oz/yd² | Yes (Within acceptable range for equivalence) |
| Thickness | - | 10.0 mils | 9.4 mils | Yes (Within acceptable range for equivalence) |
| Viral Penetration | ASTM F1671 | Not explicitly listed, but implied predicate also meets this. | Tested under ASTM F1671 | Yes (Tested, implied compliance) |
| Synthetic Blood Penetration | ASTM F1670 | Not explicitly listed, but implied predicate also meets this. | Tested under ASTM F1670 | Yes (Tested, implied compliance) |
| Biocompatibility (Surface devices, intact skin, limited duration < 24 hours) | ISO 10993 | Not explicitly listed, but implied predicate also meets this. | Meets requirements per ISO 10993 | Yes (Tested, implied compliance) |
Notes on Acceptance Criteria: The "acceptance criteria" here are largely implicit, aiming to demonstrate that the Medline gown performs at least as well as or similarly to the legally marketed predicate device, especially concerning barrier properties and safety.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only states that the gowns "have been tested" under the ASTM standards and "meet the requirements" for biocompatibility. The quantity of gowns or material samples used for these tests is not provided.
- Data Provenance: The tests are stated to have been performed by Medline Industries, Inc. (or commissioned by them). The nature of the testing is non-clinical (laboratory testing of material properties/barrier performance). No country of origin for the data is explicitly mentioned beyond the submitter's location (Mundelein, IL). It is inherently retrospective as these tests would have been completed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for the performance claims (viral penetration, synthetic blood penetration, biocompatibility) is established through standardized laboratory tests (ASTM F1670, F1671, ISO 10993), not expert consensus on clinical cases. The interpretation of these test results would be conducted by qualified laboratory personnel following established protocols, rather than a panel of experts establishing a "ground truth" for each sample.
4. Adjudication Method for the Test Set:
- None. As the "study" involves laboratory testing against objective standards (e.g., pass/fail for penetration, compliance with ISO 10993), there is no human adjudication method like 2+1 or 3+1 typically used for clinical image interpretation or diagnosis. The results are quantitative or qualitative assessments based on standardized methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted or described. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. This submission pertains to a surgical gown, which is a physical barrier device, not a diagnostic tool requiring human interpretation of cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This question is not applicable. The device is a surgical gown, not an algorithm or AI system. Its performance is assessed directly through material and barrier property testing, not through algorithmic output.
7. Type of Ground Truth Used:
- The "ground truth" for the performance claims is based on standardized laboratory test results (e.g., meeting the requirements of ASTM F1670 for synthetic blood penetration, ASTM F1671 for viral penetration, and ISO 10993 for biocompatibility). These are objective measurements and assessments against specified scientific standards, not expert consensus on patient outcomes or pathology.
8. Sample Size for the Training Set:
- Not applicable. This submission is for a physical medical device (surgical gown), not a machine learning model or an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
In summary, the provided document details a regulatory submission for a surgical gown, demonstrating substantial equivalence through non-clinical testing. The "acceptance criteria" are met by showing performance consistent with regulatory standards and comparable to a predicate device, through standardized laboratory tests rather than complex clinical trials or expert-adjudicated datasets.
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Medline Industries, Inc.
OCT 2 8 1998
Image /page/0/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font. Above and below the word are two parts of a star shape. The top part of the star is above the word, and the bottom part of the star is below the word.
One Medline Place Mundelein, Illinois 60060.4486
1-847-949-2639 WATS: 1-800-950-0128 Fax: 1-847-949-2643
Lara N. Simmons Director of Regulatory Affairs 510(k) SUMMARY
July 13, 1998
-
- Submitters Information: Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Phone: 847-949-2639 847-837-2787 Fax: Lara Simmons, Corporate Regulatory Affairs Contact:
-
- Device Information:
- Trade Name: Medline Disposable Sterile Zoned Impervious Surgical Gowns A.
- Sterile Disposable Surgeon's Gowns B. Common Name:
- Surgical Gown C. Classification Name:
- 79FYA Class II Device Panel and ProCode: D.
3. Substantial Equivalence Claim: Medline claims substantial equivalence to Johnson & Johnson Medical, Inc.'s Barrier Fabric 450 Surgical Gown, K934608.
4. Device Description:
Medline Disposable Sterile Zoned Impervious Surgical Gowns are manufactured from a non-woven fabric which is laminated to a plastic film. Because the plastic film is made of microporous polyethylene, it provides protection from inward liquid penetration as well as comfort by allowing outward passage of vapor. These products are disposable and intended for single use only.
The Sontara Spunlace Fabric is produced by DuPont. It is a hydroentangled (or hydrolaced) fabric made using a Spunlace technology. For medical applications, the content is approximately 55% wood pulp and 45% polyester. The interlaced fibers and surface finish give Sontara outstanding barrier properties while providing the comfort features of re-usable linens.
This product has seams which are bound to provide strength and barrier properties. Tape is utilized to cover the drill holes required during manufacturing. There are long stockinet cuffs on the sleeves for added comfort and protection. Both Velcro and snaps are offered as closures. The materials used in Medline's gowns are strong, do not unravel or delaminate and are low in lint.
-
- Intended Use:
Medline Disposable Sterile Zoned Impervious Surgical Gowns are surgical apparel that is intended to be worn by operating room personnel during surgical procedures to protect
- Intended Use:
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Medline Industries, Inc.
Image /page/1/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a stylized, italicized font. Above the word, there is a symbol resembling a compass or a star with four points. The symbol is black, matching the color of the text, and it is positioned directly above the center of the word "MEDLINE".
One Medline Place Mundelein, Illinois 60060.4486
1-847-949-2639 WATS: 1-800-950-0128 Fax: 1-847-949-2643
Lara N. Simmons Director of Regulatory Affairs
both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
-
- Technological Characteristics:
There are no technological differences between the new device and the predicate device. They are both made from material that is functionally the same.
- Technological Characteristics:
-
- Non-Clinical Performance Data:
| Feature | Medline | Predicate |
|---|---|---|
| MaterialComposition | Sontara Spunlace – a Non-Wovenhydroentangled (or hydrolaced)fabric made using a SpunlaceTechnology | Johnson & Johnson Fabric 450 is anon-woven hydroentangled fabricmade using a spunlace technology |
| Weight Per SquareYard | 1.70 oz/yd² | 2.1 oz/yd² |
| Thickness | 9.4 mils | 10.0 mils |
The safety and effectiveness of Medline Disposable Sterile Zoned Impervious Surgical Gowns are dependent upon proper usage of the product. When used per the instructions, these products provide a barrier to help prevent contamination of the otherwise sterile fields during medical and surgical procedures and provide a protective barrier to help prevent the migration of blood-borne pathogens.
- Viral Penetration and Synthetic Blood Penetration Studies. 8. Medline Industries, Inc. Zoned Impervious Surgical Gowns have been tested under both ASTM F1670 (Synthetic Blood Penetration) and ASTM F1671 (Viral Penetration).
-
- Biocompatibility
These devices meet the requirements for biocompatibility per ISO10993 for surface devices, intact skin, limited duration (<24 hours).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 1998
Ms. Lara Simmons Corporate Requlatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
Re : K982693 Medline Disposable Sterile, Surgical Gowns Trade Name: Zoned Impervious Requlatory Class: II Product Code: FYA Dated: July 13, 1998 Received: August 3, 1998
Dear Ms. Simmons:
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 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Simmons
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberibed in your in 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 requlation (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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INTENDED USE
510(k) Number (if known): (N/A)
Device Name: Medline Disposable Sterile Surgical Gowns, Zoned Impervious
Indications for Use:
Medline Disposable Sterile Surgical Gowns, Zoned Impervious are surgical apparel that is intended to be wom 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Division Sign-Off) (Optional Format 1-2-96)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K 982693
§ 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.