(114 days)
BRIGHTWAY™ Brand Nitrile Examination Glove ( Powder Free, Chlorinated, Black Color ) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
BRIGHTWAY™ Brand Nitrile Examination Gloves (Powder Free, Chlorinated, Black Colour)
Here's an analysis of the provided text regarding acceptance criteria and study information:
The provided text describes two distinct medical devices and their respective 510(k) submissions. I will analyze the information for each separately as they don't seem to be related.
Device 1: SafeTip Safety Syringe (KOGO402)
This document mentions testing in a very general way and does not provide specific acceptance criteria or detailed study information. It states:
"The Devon SafeTip Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005."
From this, we can infer that the device was tested against "internationally recognized standards for syringe performance" and the "FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005." However, the specific metrics, thresholds, or details of the study itself are not present.
Given the information provided, it's impossible to fill out the requested table and answer many of the specific questions.
Device 2: BRIGHTWAY™ Brand Nitrile Examination Gloves (K060402)
This document is a 510(k) clearance letter for examination gloves. It does not contain any information about specific acceptance criteria or performance studies of the device. It primarily details the regulatory clearance process and refers to general controls. The "Indications for Use" section simply describes the intended use of the gloves.
Therefore, for this device, it's also impossible to fill out the requested table and answer the specific questions about acceptance criteria and studies.
Summary of Missing Information for BOTH Devices:
The provided texts are regulatory submission documents (or summaries thereof) that indicate a device has undergone testing and met certain standards, but they do not include the specific details of those tests, acceptance criteria, or study methodologies. To answer your questions fully, you would need access to the actual test reports or detailed study summaries that would have been part of the full 510(k) submission.
Attempting to fill what little can be inferred from the "SafeTip Safety Syringe" document, with heavy caveats:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Inferred) | Acceptance Threshold (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|---|
| Syringe Performance | Not specified (e.g., fluid delivery accuracy, plunger force) | Not specified (e.g., +/- X%, < Y N) | "Meets internationally recognized standards for syringe performance" |
| Safety Feature Reliability | Prevention of accidental needle sticks post-injection | 100% or very high percentage of successful sheath deployment | "Demonstrated... reliability of the safety feature" |
| Conformity to Guidance | Adherence to FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005 | Full compliance | "In accordance with the FDA Guidance" |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: "Simulated clinical use testing" is mentioned, implying controlled laboratory or simulated environment. Country of origin not specified, but the applicant (Devon Safety Products) is based in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. Testing likely involved engineers and technicians, not medical experts establishing ground truth in the traditional sense for diagnostic AI.
4. Adjudication method for the test set
- Not applicable as the study involves functional performance testing, not expert interpretation.
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 is a physical device performance study, not an AI diagnostic study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical device performance study.
7. The type of ground truth used
- The "ground truth" would be the objective measurement of the device's functional performance against established engineering and safety standards (e.g., successful deployment of the safety sheath, accurate fluid delivery, material strength, etc.).
8. The sample size for the training set
- Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the AI/machine learning sense.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
Conclusion for both devices: The provided text is insufficient to answer most of your detailed questions regarding acceptance criteria and study specifics. This information is typically found in detailed test reports and clinical study summaries, not typically in the brief 510(k) summary or clearance letters themselves.
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JUN - 9 2006 KOGO402
Submitted on behalf of:
Devon Safety Products
DBA Devon Medical Supplies 1100 First Avenue, Suite 100 King Of Prussia, PA 19406 Telephone: 1-800-431-2273 Fax: Fax: Fax: Fax: Fax: 610-768-4509
Submitted by:
Paladin Medical, Inc. P.O. Box 560
Telephone: Fax:
Stillwater, MN 55082 715-549-6035 715-549-5380
CONTACT PERSON: Elaine Duncan
DATE PREPARED: March 10, 2006 TRADE NAME: SafeTip Safety Syringe COMMON NAME: Safety Syringe REGULATION: Piston Syringe: 21 CFR 880.5860: Class II General Hospital
SUBSTANTIALLY EQUIVALENT TO:
The Devon Medical Supplies SafeTip Syringe is substantialTy equivalent to the Medisys Tech. CoverTip Safety Syringe for technological features, the Becton Dickinson Integra Syringe in performance and the Devon Standard Syringe for materials.
DESCRIPTION of the DEVICE:
The SafeTip Safety Syringe is a piston syringe that features a passive sharp safety feature which covers the needle after injection. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp needle after removal.
INDICATIONS FOR USE:
The SafeTip Syringe is indicated for use in the administration of an intramuscular (IM) injection. The SafeTip Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection
SUMMARY of TESTING:
The Devon SafeTip Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
SEP 2 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. G. Baskaran Group Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah Klang, Selangor, Darul Ehsan MALAYSIA 42100
Re: K060402
Trade/Device Name: BRIGHTWAY™ Brand Nitrile Examination Gloves (Powder Free, Chlorinated, Black Colour) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 31, 2006 Received: June 7, 2006
Dear Mr. Baskaran:
This letter corrects our substantially equivalent letter of June 13, 2006.
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 (PMA). 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 (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.
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Page 2 - Mr. Baskaran
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), nlease contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sutte y. Michael. M.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 1
Indications for Use
:
:
510(k) number
K 060402
Device Name
BRIGHTWAY™ Brand Nitrile Examination Gloves ( Powder Free, Chlorinated, Black Color )
Indications for use:
BRIGHTWAY™ Brand Nitrile Examination Glove ( Powder Free, Chlorinated, Black Color ) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Prescription Use ( Part 21 CI'R 801 Subpart D ) AND / OR
Over -- The - Counter Use _ ( Part 21 CFR 801 Subpart C )
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEI) )
Concurrence of CDRH, Office of Device Evaluation ( ODE )
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§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.