(116 days)
The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.
The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back
The provided text describes the acceptance criteria and the study for a Disposable Apron manufactured by Instrument Makar, Inc. The study focuses on viral penetration testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Viral Penetration (ASTM Method F1671-95) based on the K955835 Fluid Barrier Boot study:
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Viral Penetration | No oX174 bacteriophage detected on the assay plates after challenge. (Based on passing results of Fluid Barrier Boot, which uses the same material) | Thirty-two (32) samples of the Fluid Barrier Boot (made from the same 6-gauge embossed Poly-Vinyl as the apron) were tested. All thirty-two passed, showing no oX174 on the assay plates after being challenged with a oX174 bacteriophage suspension at a concentration of approximately 1.3 x 108 PFU/ml. |
| Compatibility Ratio | Compatibility ratio for the material and test organisms should be acceptable to ensure the integrity of the test. (The text implies this was met for the Fluid Barrier Boot study, which is referenced for the apron's material). | The compatibility ratio for the Fluid Barrier Boot was 1.3. |
| Challenge Level | The oX174 bacteriophage challenge suspension must be maintained at a concentration of at least 1.0 X 108 PFU/ml. | The challenge level was maintained at ~1.3 x 108 PFU/ml. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: 32 samples (referred to as "Fluid Barrier Boot" samples, which are made from the same material as the apron).
- Data Provenance: The document does not specify the country of origin of the data. It appears to be an internal study conducted to support a 510(k) submission, suggesting it's retrospective as per common regulatory processes where testing precedes submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This study involves non-clinical testing (viral penetration testing) of a material, not human interpretation or diagnosis. Therefore, there are no "experts" establishing a ground truth in the traditional sense of clinical studies. The "ground truth" is determined by laboratory assay results (presence/absence of bacteriophage).
4. Adjudication Method for the Test Set
N/A. As stated above, this is laboratory testing, not a clinical study involving human interpretation. The outcome (presence/absence of bacteriophage) is determined by objective laboratory assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a non-clinical, material-level performance study, not a clinical MRMC study involving human readers or comparative effectiveness with or without AI.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This is a non-clinical material test, not an algorithm performance study.
7. The Type of Ground Truth Used
The ground truth used is objective laboratory assay results for the presence or absence of the oX174 bacteriophage following a controlled challenge. This is a direct measurement of viral penetration through the material.
8. The Sample Size for the Training Set
N/A. This is a non-clinical performance test for a physical product (apron material), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for an AI algorithm, this question is not applicable.
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FEB 2 5 1997
510(k) Summary of Safety and Effectiveness
| Submitter: | Instrument Makar, Inc2950 E Mt. Hope RoadOkemos, MI 48864 | Date of SummaryK964364 | 2/20/97 |
|---|---|---|---|
| Phone: | (517)332-3593 | ||
| Fax: | (517)332-2043 | ||
| Contact: | Autumn Johnson | ||
| Product: | Classification Name:Generic Name:Trade/Proprietary Name: | Surgical Apparel (21 CFR 878.4040)ApronDisposable Apron |
Substantially Equivalent Product:
Sloan Medical, Disposable Surgical Jumpsuit Associated Bag, Apron
Description:
The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back
Intended Use:
The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient
The Disposable Apron is a disposable product intended for single use only.
Summary of the non-clinical tests from which substantinl equivalence:
The Disposable Apron has the sume intended use as Sloan Medical's Disposable Surgical Jumpsuit and Associated Bag's Apron. The designs are similar in that they both are scoured the neck and tied behind the back. The also cover the front of the following table summanzes the non-clinical tests from which the substantial equivalence is based.
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| Sloan Medical | Associated Bag | Instrument Makar | |
|---|---|---|---|
| Jumpsur | Apron | Apron | |
| Intended Use | Protect user from fluidsin hospital environment | Protect user from fluidsin hospital environment | Protect user from fluidsin hospital environment |
| Design | Ties around the neckand behind the back | Ties around the neckand behind the back | Ties around the neckand behind the back |
| Materials | 2 mil Polyethylene | 1 1/4 mil Polyethylene | 6 Gauge EmbossedPoly-Vinyl |
| Physical Safety | NA | NA | NA |
| Target Population | Hospital Personnel | Hospital Personnel | Hospital Personnel |
| Biocompatibility | Jumpsuit is worn overclothing, therefore willnot be in contact withuser's skin | Apron is worn overclothing, therefore willnot be in contact withuser's skin | Apron is worn overclothing, therefore willnot be in contact withuser's skin |
| Anatomical Sites | Cover front of body andfeet | Cover front of body andfeet | Cover front of body andfeet |
| Additional Notes | Sold non-sterile | Sold non-sterile | Sold non-sterile |
Summary of the Viral Penetration Test: ASTM Method F1671-95
The matcrial from which the Apron is made, 6 gauge embossed Poly-Vinyl, is the same as Instrument Makar's Fluid Barrier Boots(K955835) are made
Summary:
:
The oX174 bacteriophage challenge suspension will be maintained at a concentration of at least 1.0 X 108 PFU/ml (plaque forming units/mL).
Test samples were propared by randomly cutting approximately 75mm x 75mm test swatches from the test material. Test samples were challenged with approximately 60 mL of a oX 174 bacteriophage suspension for 5 minutes at atmospheric pressure, 1 minute at 2.0 PSIG (13.8 kpa), and 54 minutes at atmospheric pressure or until liquid penetration was observed. At the conclusion of the test, the observed side of the test sample was rinsed with a sterile assay medium and then assayed for the presence of the oX 174 bacteriophings. The surface tension of the challenge suspension and the assay medium was adjusted to approximately 40-44 dynes/em using surf actant-type Tweents 80 at a final concentration of approximately 0.01% by volume.
These samples were also tested for computibility of materials and test organisms. This testing was done by placing a 10 uL aliquot of a 0X174 suspension containing a total of 900-1200 PFU near the center of the test sample after it had been clamped into the penetration test cell. After 60 minutes, the surface was rinsed with a sterile assay medium and then assayed for the presence of the oX174 bacteriophage
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Results·
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The compatibility ratio for the Fluid Barner Boot was 1 3 - The challenge level was manitanced at -1.3 x 108 PFU/ml
Thirty two samples of the Fluid Barrier Boot were tested according to the procedure described in this report All thirty two passed showing no oX174 on the assay plates.
§ 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.