(213 days)
Not Found
No
The device description details a purely mechanical device with a spring-activated insertion mechanism and a physical safety feature. There is no mention of any computational or learning components.
No
The device aids in syringe insertion and prevents needle reuse; it does not directly treat or diagnose a medical condition. Its function is mechanical assistance for drug delivery, not therapy itself.
No
The device is described as aiding in the insertion of a syringe needle for medication dispensation and preventing needle reuse, with no mention of diagnosing conditions or collecting diagnostic information.
No
The device description explicitly states it is constructed of physical components (polycarbonate, spring, housing) and is a single-use non-sterile device intended to aid in syringe insertion, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the insertion of a commercially available syringe" and prevent needle reuse. This is a mechanical function related to drug delivery, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a mechanical device that assists with syringe insertion and has a safety feature. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing specimens, detecting analytes, or any other activities typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
KZH
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Personal Injections
Hospitals
Clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
APR 1 2 2004
| 510(k) Notification
MedSolve LLC | MedSafe™ System Inserter | K032848
Page 10 of 38 |
| ------------------------------------- | -------------------------- | -------------------------- |
|---|
Section E - 510K Summary
| Submitter: | MedSolve LLC
1140 Highland Avenue #222
Manhattan 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
1
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:
-
- 21 CFR 820, Codc of Federal Regulations
-
- 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
2
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
3
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 Inserter
K032848 | Inject-Ease
K872233 |
|--------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | Aid in the insertion of a
commercially available
syringe into patient | Aid in the insertion of a
commercially available
syringe into patient |
| Users | Personal Injections
Hospitals
Clinicians | Personal Injections
Hospitals
Clinicians |
| 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 for
used syringe/needle | Entire device is discarded in
sharps container. | Syringe is manually
removed and discarded in
sharps 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.
4
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.
5
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.
6
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
7
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