This device is used in conjunction with a commercially available syringe to aid in the insertion of the syringe needle. The device is constructed of thick walled rigid polycarbonate injection molded components, and a spring, that are permanently assembled within a housing. The devices are provided bulk non-sterile to the user. The user fills a standard syringe and places it in the device. The user positions the device against the injection site. The safety feature is unlocked by rotating the moving carrier. The insertion spring is activated by pressing the device against the skin at the injection site. This spring advances the syringe such that the needle penetrates the skin. The user dispenses the medication by depressing the syringe plunger. Two 'legs' snap over the plunger at the end of the injection stroke to capture the syringe plunger. The device is disposed of in appropriate sharps containers according to local, state, and Federal regulations.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device (MedSafe™ System Inserter) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or reader improvement with AI).

Instead, the submission demonstrates compliance with voluntary standards and compares the device's features to a predicate device to argue for substantial equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative "acceptance criteria" for device performance in terms of metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are implied to be compliance with voluntary standards and demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device "Performance" (Comparison to Predicate)
Compliance with Voluntary Standards:
- 21 CFR 820 (Quality Systems)	Device is stated to be in compliance. (Compliance is an implicit standard for manufacturing and quality).
- 21 CFR 801 or 809 (Labeling)	Draft labeling contained in the submission. (Implied compliance through submission).
- EN46001, EN ISO 9001 (Quality Systems)	Device is stated to be in compliance.
- 49 CFR 178.603 (DOT Drop Test)	Device is stated to be in compliance.
- ISO 15223 (Medical Device Symbols)	Device is stated to be in compliance.
Substantial Equivalence to Predicate Device (K872233 - Inject-Ease):
- Intended Use	MedSafe™: Aid in the insertion of a commercially available syringe into patient; safety feature prevents needle reuse. Predicate: Aid in the insertion of a commercially available syringe into patient.
- Users	MedSafe™: Personal Injections, Hospitals, Clinicians. Predicate: Personal Injections, Hospitals, Clinicians.
- Compatible Syringes	MedSafe™: Various by model. Predicate: Various by model.
- Insertion Mechanism	MedSafe™: Metal Spring. Predicate: Metal Spring.
- Housing Material	MedSafe™: Rigid Plastic - opaque. Predicate: Rigid Plastic - opaque.
- Sterility	MedSafe™: Non Sterile. Predicate: Non Sterile.
- Disposal Method	MedSafe™: Entire device is discarded in sharps container. Predicate: Syringe is manually removed and discarded in sharps container.
- Biocompatibility	MedSafe™: Accessory Device. Predicate: Accessory Device.

2. Sample sized used for the test set and the data provenance:

The document does not describe a test set or data provenance because it's a 510(k) submission focused on substantial equivalence based on design and function comparison, not a performance study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no such test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no test set is described.

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:

No. This document describes a mechanical syringe inserter, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study related to AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This description is for a mechanical device; there is no algorithm involved.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable as no specific ground truth for performance evaluation (in the medical imaging/AI sense) is discussed. The "ground truth" for this device's acceptance is its compliance with manufacturing standards and its functional equivalence to a legally marketed predicate.

8. The sample size for the training set:

Not applicable as this is a mechanical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable as no training set is relevant for this device.

Summary

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APR 1 2 2004

510(k) NotificationMedSolve LLC	MedSafe™ System Inserter	K032848Page 10 of 38
-------------------------------------	--------------------------	--------------------------

Section E - 510K Summary

Submitter:	MedSolve LLC1140 Highland Avenue #222Manhattan Beach, CA 90266(310) 939-9088
------------	------------------------------------------------------------------------------------------

Contact: Susan McConnell 4635 Gershwin Place Woodland Hills, CA 91364 (818) 223-8537 (818) 223-8579 FAX

Name of Device: MedSafe™ System Inserter

Generic Device Name: Syringe Insertion Device

Classification: General Hospital, 21 CFR880 Type II

Product Code	KZH
Regulation Number	Section 880-6920
Classification Name	Introducer,Syringe Needle

Establishment Registration: MedSolve LLC has not yet obtained an Establishment

Registration Number.

Manufacturing Facility: Manufacturing location has not yet been determined.

File 101/103

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Performance Standards: No performance standards applicable to this device have been

establish under Section 514 of the Act. The device is in compliance with the following

voluntary standards:

1. 21 CFR 820, Codc of Federal Regulations
1. 21 CFR 801 or 809, Code of Federal Regulations
EN46001, Quality Systems Medical Devices Particular Requirements for the Application of 3. EN ISO 9001
49 CFR 178.603, Department of Transportation (DOT) Drop Test 4.
ISO 15223, Medical Devices Symbols to be used with medical device labels, labeling, and 5. information to be supplied.

Labeling: Draft labeling is contained in the submission.

Product Description:

This device is used in conjunction with a commercially available syringe to aid in

the insertion of the syringe needle.

The device is constructed of thick walled rigid polycarbonate injection molded

components, and a spring, that are permanently assembled within a housing. The devices

are provided bulk non-sterile to the user.

The user fills a standard syringe and places it in the device. The user positions the

device against the injection site. The safety feature is unlocked by rotating the moving

carrier. The insertion spring is activated by pressing the device against the skin at the

injection site. This spring advances the syringe such that the needle penetrates the skin.

The user dispenses the medication by depressing the syringe plunger.

File 101/103

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Two 'legs' snap over the plunger at the end of the injection stroke to capture the syringe plunger. The device is disposed of in appropriate sharps containers according to local, state, and Federal regulations.

Predicate Device: Palco Inject-Ease, 510K Number: K872233

Intended Use of the New Device: Single-use non-sterile device intended to aid in the insertion of a commercially available syringe. The Safety feature prevents needle reuse. Substantial Equivalence:

Technologically, both insertion devices are spring driven devices that require the user to load the syringe into the housing, and then insert the syringe needle into the patient injection site.

The difference between the new device and the predicate disposal device is that the MedSafe™ Inserter inserts the syringe needle by pressing the device against the inscrtion site rather than requiring the user to push a trigger. A locking feature on the MedSafe™ Inserter device prevents accidental activation.

Another difference between the new device and the predicate insertion device is that there is no requirement for the user to set insertion depth. Model 200 of the MedSafe™ System Inserter is designed for the specific manufacturer's syringe design, syringe size, and necdle length specified. The predicate device requires the user to add a 'spacer' to adjust needle penetration depth.

File 101/103

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Another difference between MedSafe™ and Inject-Ease is that MedSafe™ is designed as a single use disposable device rather than a reusable device. Thus, the MedSafe™ System Inserter does not require removal of the syringe for disposal nor does it require cleaning.

The comparison table indicating the device is substantially equivalent ' to the

predicate device is shown below:

Feature	MedSafe™ System InserterK032848	Inject-EaseK872233
Intended Use	Aid in the insertion of acommercially availablesyringe into patient	Aid in the insertion of acommercially availablesyringe into patient
Users	Personal InjectionsHospitalsClinicians	Personal InjectionsHospitalsClinicians
Compatible Syringes	Various by model	Various by model
Insertion Mechanism	Metal Spring	Metal Spring
Housing material	Rigid Plastic - opaque	Rigid Plastic - opaque
Sterility	Non Sterile	Non Sterile
Disposal Method forused syringe/needle	Entire device is discarded insharps container.	Syringe is manuallyremoved and discarded insharps container.
Biocompatibility	Accessory Device	Accessory Device

Confidentiality: This submission and information contained in this submission and its attachment is considered confidential, proprietary information of MedSolve LLC and a trade secret until such time as the Company distributes such information publicly.

File 101/103

1 The term "substantially equivalent" as used in this submission is intended to convey only a determination of substantial equivalence pursuant to the requirements of the Federal Food and Drug and Cosmetic Act. [t is not intended to have any relation in determining what is patentable or on the resolution of patent infringement suits or on other patent matter.

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Applicable provisions of the Freedom of Information Act govern the release of information contained herein and pertinent FDA regulations contained in 21 CFR, Parts 20 and 800. Should the FDA contemplate release of any information contained herein, the Company hereby requests prior notice to any such release, consistent with 21 CFR 20.15 and other pertinent sections affording similar rights.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings of the symbol. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

APR 12 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MedSolve Technologies LLC C/O Ms. Susan McConnell Principal Susan McConnell 4635 Gershwin Place Woodland Hills, California 91364

Re: K032848

Trade/Device Name: MedSafe™ System Inserter Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: February 19, 2004 Received: February 20, 2004

Dear Ms. McConnell:

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 cither 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.

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Page 2 - Ms. McConnell

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 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), please contact the Office of Compliance at (301) 594-5618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

for
I

hiu 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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Ko32848

K032848 Page 9 of 38

Section D - Statement of Indications for Use

Applicant: MedSolve LLC

510 (K) Number:_______________________________________________________________________________________________________________________________________________________________ _K032848

Device Name: MedSafe™ System Inserter

Indications for Use:

Single-use non-sterile device intended to aid in the insertion of a commercially available syringe. The Safety feature prevents needle reuse.

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED ・

Prescription Use	or Over-The-Counter Use
	(Per 21 CFR 801)
	for ADW 4/8/04(Division Sign-Off)Division of Anesthesiology, General Hospital,Infection Control, Dental Devices
510(k) Number:	K032848

File 101/103

Regulation Number and Section

§ 880.6920 Syringe needle introducer.

(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).