(79 days)
The B.I.GTM. Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.
The B.I.GTM. Bone injection Gun for Pediatrics is an instant, intravascular (IV) access device. The device comprises a housing with a spring loaded mechanism that inject a trocar needle into the bone marrow of a patient and allows for subsequent connection of a syringe or intravascular administration set.
This document is a 510(k) summary for the WaisMed LTD. B.I.G.TM - Bone Injection Gun for Pediatrics. It is a premarket notification for a medical device and, as such, does not typically contain the detailed information requested regarding clinical studies with specific acceptance criteria, sample sizes for training/test sets, ground truth establishment, or expert involvement in the way a clinical trial report or a journal publication would.
The provided document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed de novo clinical study with quantitative performance metrics against pre-defined acceptance criteria.
I can, however, extract related information to address some of your points based on what is available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence based on technological features, principles of operation, and intended use, rather than presenting specific quantitative performance data against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The summary states "supportive data including in vitro studies, clinical data and literature survey," but does not specify sample sizes, country of origin, or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The 510(k) summary does not describe any specific process for establishing ground truth involving experts. It relies on the clinical context of intraosseous access for emergencies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As an adjudication method would typically be part of a detailed clinical study, its absence is consistent with the nature of a 510(k) summary focused on substantial equivalence.
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
This information is not applicable/provided. The device is a mechanical bone injection gun, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a mechanical device for gaining intraosseous access, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in the context of the requested detailed study. However, for a device like an intraosseous access gun, the "ground truth" for its effectiveness would inherently relate to the successful establishment of intraosseous access and its ability to deliver fluids/medications. This would typically be confirmed by direct observation during use, fluid flow, and patient physiological response, which falls under outcomes data in a broad sense (i.e., whether the device successfully achieves its intended physical function). The 510(k) summary states it provides "intraosseous access in the proximal tibia, as an alternative to IV access during emergencies." The "clinical data" mentioned would likely pertain to demonstrating this function.
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" in the context of machine learning. The device is mechanical.
9. How the ground truth for the training set was established
This information is not provided/not applicable as there is no training set for a machine learning model.
Summary of available information from the 510(k) Summary:
The 510(k) summary primarily asserts substantial equivalence to predicate devices based on:
- Intended Use: To provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies, for pediatric patients up to 12 years of age.
- Technological Features and Principles of Operation: Stated to be the same as the predicate Adults' B.I.G.TM device.
- Performance Data: "Supportive data including in vitro studies, clinical data and literature survey" were used to demonstrate that minor differences from predicate devices do not raise new types of safety or effectiveness issues. However, specific details of these studies (acceptance criteria, sample sizes, ground truth, etc.) are not provided in this summary.
This type of 510(k) summary is common for devices demonstrating substantial equivalence, where the focus is on showing similarity to already cleared devices rather than presenting a novel device with extensive new clinical trial data against pre-defined performance thresholds.
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510(K) SUMMARY
WaisMed LTD. B.I.GTM- Bone injection Gun for Pediatrics
WaisMed Ltd. Applicant: P.O. Box 3582 Industrial Zone Caesarea, 38900 ISRAEL Tel: 011-972-4-6309632 Fax: 011-972-4-9230630 E-Mail: mickey@waismed.com
Contact Persons:
Dorit Winitz, Ph.D. Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 011-972-9- 7718130 Fax: 011- 972-9-7718131 E-mail: dorit@push-med.com
Trade Name:
B.I.GTM- Bone Injection Gun for Pediatrics
Classification Name:
Needle, Hypodermic, Single Lumen
Predicate Devices
- The Bone Injection Gun Device (Waismed Ltd.), cleared . under K981853
- The Intraosseous Access Needles (Cook Inc.), cleared . under K915409, K913258
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Intended Use:
The B.I.GTM- Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.
Device Description:
The B.I.GTM. Bone injection Gun for Pediatrics is an instant, intravascular (IV) access device. The device comprises a housing with a spring loaded mechanism that inject a trocar needle into the bone marrow of a patient and allows for subsequent connection of a syringe or intravascular administration set.
Performance Data & Substantial Equivalence:
The B.I.GTM. Bone injection Gun for Pediatrics, like both its predicates; the Adults' Model of the B.I.G.TM device and the Cook intraosseous Access Needles, is intended to provide intraosseous access as an alternative to intravascular access during emergencies. As the adult's model of the B.I.G.TM device it is limited for use in the proximal tibia and similarly to the Cook intraosseous Access Needles, the B.I.G.TM device is intended for use in the pediatric population.
The B.I.G™. Bone injection Gun for Pediatrics has the same technological features and principles of operation as the predicate Adults' B.I.G.TM device. Any minor differences in these aspects between the systems do not raise new types of safety or effectiveness issues as demonstrated by a supportive data including in vitro studies, clinical data and literature survey.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WaisMed Limited C/O Dr. Dorit Winitz Push-med Limited 117 Ahuzah Street Ra' anana 43373 ISRAEL
Re: K022415
Trade/Device Name: Bone Injection ( B.I.G.) for Pediatrics Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 21, 2002 Received: July 24, 2002
Dear Dr. Winitz:
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. 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 such 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 statutes and regulations administered by other Federal agencies.
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Page 2 - Dr. Winitz
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 begin 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy J. Ulatowski
Timothy A. Ulatowski 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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INDICATIONS FOR USE STATEMENT
510(k) Number: K022415
Device Name:
B.I.GTM. Bone injection Gun for Pediatrics
Indications for Use:
The B.I.G™. Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.
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510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use _ ﮯ (Per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Patricia Cucenta
Division of Anesthesiology, General Hos Infection Control, Dental Dev
510(k) Number: K022415
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§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).