(99 days)
No
The device description and performance studies focus on the physical components and standard testing for a manual insulin syringe, with no mention of AI or ML.
No
The device is an insulin syringe, used for administering medication (insulin), but it does not directly provide therapeutic treatment itself. The therapeutic effect comes from the insulin, not the device.
No
Explanation: The device description clearly states its purpose is for the "manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin." It does not mention any function for diagnosing conditions.
No
The device description clearly states it is a sterile device consisting of physical components like a barrel, needle, needle cover, and end cap, made of materials like Polypropylene and TPE. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the manual aspiration and injection of insulin into the body. This is a direct medical intervention on a patient.
- Device Description: The device is a syringe with a needle, designed for delivering a substance into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on a specimen.
The device described is a medical device used for drug delivery, specifically insulin.
N/A
Intended Use / Indications for Use
The sterile Insulin Syringe is for single use, with the callbrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.
Product codes
FMF
Device Description
The proposed device, Insulin Syringe, is a sterile device consisting of a calibrated hollow barrel, needle, needle cover and end cap. The Insulin syringe is intended for medical purpose for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The device is intended to be used for adults only. The needle is fixed on the syringe. The syringes barrel and plunger is made up of Polypropylene, the gasket is of Thermo Plastic Elastomer (TPE) and the needle cover (Top Cap) and end cap (Bottom Cap) is made up of polypropylene.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin
Indicated Patient Age Range
adults only
Intended User / Care Setting
Not Found
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)
Performance testing was conducted to ensure the substantial equivalence of the Insulin syringe throughout the shelf life and verify conformity to the applicable parts of ISO standards. No new question of safety and effectiveness were raised with the testing performed on the subject device when compared to the predicate device. The following performance tests were performed on the Insulin syringe using a fixed needle:
(i) ISO 7864:2016, Sterile hypodermic needles for single use -- Requirements and test methods
(ii) ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods
(iii) ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin
Biocompatibility testing was conducted:
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
- Acute systemic toxicity
- Pyrogenicity
- Hemocompatibility
- Subacute systemic toxicity
Sterilization, Shipping and shelf life testing:
- (i) EO sterilization validation as per ISO11135-2014
- (ii) Pyrogen testing as per USP Bacterial Endotoxin Test
- (iii) EO residual as per ISO 10997-7
- (iv) Stimulated shipping as per ASTM D4169
- (v) Sterile barrier Package testing performed on the proposed device (ISO 11138, IP)
- (vi)Seal strength EN 868-5
- Bubble test ASTM 2096 (vii)
- Dye Penetration ASTM F1929-15 (viii)
Shelf life of 5 years validated using FDA recognized ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
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
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 6, 2024
SPM Medicare Pvt. Ltd. % Prithul Bom, Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114
Re: K233794
Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: March 6, 2024 Received: March 6, 2024
Dear Prithul Bom:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233794
Device Name Insulin Syringe
Indications for Use (Describe)
The sterile Insulin Syringe is for single use, with the callbrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K233794 510k Summary
This 510k summary is being prepared in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
| Device Submitter: | SPM Medicare Pvt. Ltd
B-40, Phase II
Gautam Budh Nagar
Noida -201305,Uttar Pradesh, India |
|-------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Umang Mathur |
| Contact Person: | Mr. Umang Mathur |
|---|---|
| Position: | Managing Director |
| Tel : +91-971-100-8401 | |
| Email:umang@spmmedicare.com |
Designation Submission Correspondent Primary contact Person: Sanjay Kumar Position: Deputy Manager & (Management Representative) MR Tel:+91-8384011434 Email : sanjay.qa@spmmedicare.com Date of Preparation: February 7, 2024
II. DEVICE
ldentification of proposed device: Trade Name: Insulin syringe Common name: Insulin syringe
4
Regulatory Information:
Regulation Name: Piston syringe Requlatory Class: Class II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
III Predicate Device
- 510(k) Number K223453 Product Name: Insulin Svringe Regulation Number: 21 CFR 880.5860 Product Code: FMF
Manufacturer Name:
Promisemed Hangzhou Meditech Co., Ltd. Zearou Yanq Requlatory affairs manager No. 1388, Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, Zhejiang 311121, China
IV: Device Description:
The proposed device, Insulin Syringe, is a sterile device consisting of a calibrated hollow barrel, needle, needle cover and end cap. The Insulin syringe is intended for medical purpose for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The device is intended to be used for adults only. The needle is fixed on the syringe. The syringes barrel and plunger is made up of Polypropylene, the gasket is of Thermo Plastic Elastomer (TPE) and the needle cover (Top Cap) and end cap (Bottom Cap) is made up of polypropylene.
Device Range:
The proposed Insulin Syringe will be distinguished on the basis of their size and units. The 1 ml U-40 & U-100 syringes are being manufactured with different needle gauges, U-40 means 40 units of insulin in every Lm and U-100 means there are 100 units of insulin in every mL. The color code is used to identify the strength, where the red cap is used to identify U-40 units & the orange cap is used to identify U-100 units.
| S. No. | Gauge | O.D of Needle | Length of Needle |
|---|---|---|---|
| 1 | 28G | 0.349 – 0.370 mm | 6 mm, 8 mm, 12.7mm |
| 2 | 29G | 0.324 – 03.51 mm | 6 mm, 8 mm, 12.7mm |
| 3 | 30G | 0.298 – 0.320 mm | 6 mm, 8 mm, 12.7mm |
| 4 | 31G | 0.254 – 0.267 mm | 6 mm, 8 mm, 12.7mm |
| 5 | 32G | 0.229 – 0.241mm | 6 mm, 8 mm, 12.7mm |
Nominal Capacity: 1 ml (U-40). 1 ml (U-100)
5
V. INDICATIONS FOR USE
The sterile Insulin Syringe is for single use, with the calibrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.
VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
| Item | Proposed Device (K233794) | Predicate Device
K223453 | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Insulin Syringe | Insulin Syringe | Comments |
| Manufacturer | SPM Medicare Pvt. Ltd. | Promisemed Hangzhou Meditech
Co., Ltd | |
| Device Class | Class II | Class II | Same |
| Product Code | FMF | FMF | Same |
| Regulation
number | 880.5860 | 880.5860 | Same |
| Regulation Name | Piston syringe | Piston syringe | Same |
| Intended Use/
Indications for
Use | The sterile insulin syringe for
single use, with the calibrated unit
of insulin for U-40 & U-100 is a
device intended for medical
purposes for the manual
aspiration of insulin, and for the
injection of insulin into parts of the
body below the surface skin. The
device is intended to be used for
adults only. | Insulin Syringe is intended
for subcutaneous injection of
U-40 and U-100 insulin in
the treatment of diabetes. | Same |
| Type of use | Prescription use and over the-
counter use | Prescription use and over the-
counter use | Same |
| Operating Principle | The insulin is injected to
subcutaneous tissue by pushing
force generated through pushing
plunger rod of the insulin syringe. | The insulin is injected to
subcutaneous tissue by
pushing force generated
through pushing plunger rod
of the insulin syringe. | Same |
| Specific drug use | Insulin | Insulin | Same |
| Length | 118mm | 120mm | Different.
Proposed device has
118 mm length and
predicate device has
120 mm length. This
does not impact the
intended use of
device. |
| Volume | 1.0ml | 0.3ml, 0.5ml, 1.0ml | Different
Only 1.0ml insulin
syringe is included for
the subject device |
| Needle length | 6mm, 8mm, 12.7mm | 6mm, 8mm, 12mm | Different.
Compared to the
predicate device, the
proposed device has
a difference in needle
length. The 12.7mm
needle length of
theinsulin syringe
safety and
performance has
been confirmed by
testing. This
difference does not
raise new question of
safety and
effectiveness. |
| Needle gauge | 32G, 31G, 30G, 29G, 28G | 32G, 31G, 30G, 29G, 28G | Same |
| Needle tip
configuration | 3 bevels | 3 bevels | Same |
| Nozzle type | Not applicable | Not applicable | Same |
| Numbering of scale | At every 10units for 1.0ml | At every five units for the 0.3mL
and 0.5mL syringes, and at every
10units for 1.0mL | Same
The proposed
device has only
the 1.0 ml
capacity & the
predicate device
includes a 0.5mL
and 0.3ml model.
The difference in
capacity device
will be selected
by the physician
per the
patient's condition.
This difference does
not affect intended
use. |
| Gradations
legibility | Legible | Legible | Same |
| Needle cover
dimensions | Length: 25mm, Diameter: 6mm | Length: 25mm, Diameter: 6mm | Same |
| Needle cover
colour | Red (U-40) and orange (U-100) | Red (U-40) and orange (U-100) | Same |
| Lubricant
composition | Aminofuntional siloxane | Aminofuntional siloxane | Same |
| Lubricant
amount/cm2 | The lubricant does not form pools
of fluid on the interior surface of the
syringe or outside surfaces of the | The lubricant does not form
of fluid on the interior
surface of the syringe or outside | Same |
| | needle tube. | surfaces of the needle tube. | |
| Barrel transparency | Transparent | Transparent | Same |
| Needle cover
strength | 22N | >22N | Same |
| Biocompatibility | No Cytotoxicity
No irritation reactivity
No significant evidence
of skin sensitization
No significant evidence
of systemic toxicity
No evidence of Hemolysis | No cytotoxicity
No irritation reactivity No
significant evidence of
skin sensitization
No significant evidence
of systemic toxicity
No evidence of Hemolysis | Same |
| Configuration and
Material | Needle: Stainless Steel (SS304)
Barrel: Polypropylene
Plunger: Polypropylene
Piston: Polyisoprene rubber
Needle cap: Polypropylene
Protective end cap:
Polypropylene | Needle: Stainless Steel
(SS304)
Barrel: Polypropylene
Plunger: Polypropylene
Piston: Polyisoprene rubber
Needle cap: Polyethylene
Protective end cap:
Polyethylene | Different.
The materials of
the needle cap
and protective
end cap are
different
between the
proposed device
and predicate
device. The
biocompatibility
test of the
proposed device
was conducted
to demonstrate
that the subject
device met the
biocompatibility
requirements.
This difference
does not raise
any new safety
and
effectiveness
questions. |
| Label | Brand Name, Device name,
indication, instruction for use,
precaution, warning, shelf life,
manufacturer | Device name, indication,
instruction for use,
precaution, warning,
shelf life, manufacturer | Same |
| Sterilization
method and SAL | Sterilized by ethylene oxide gas
SAL = 10-6 | Sterilized by ethylene oxide gas
SAL = 10-6 | Same |
| Sterilization
method | EO Sterilization | EO Sterilization | Same |
| EO and ECH
residues testing | Conform ISO 10993-7 | Conform ISO 10993-7 | Same |
Table 1 Comparison of Technology Characteristics
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7
8
Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
VII. Performance Data
Performance testing was conducted to ensure the substantial equivalence of the Insulin syringe throughout the shelf life and verify conformity to the applicable parts of ISO standards. No new question of safety and effectiveness were raised with the testing performed on the subject device when compared to the predicate device. The following performance tests were performed on the Insulin syringe using a fixed needle:
(i) ISO 7864:2016, Sterile hypodermic needles for single use -- Requirements and test methods (ii) ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods
(iii) ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin
Biocompatibility
In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact ( Bacterial Endotoxin Test
- (iii) EO residual as per ISO 10997-7
- (iv) Stimulated shipping as per ASTM D4169
- (v) Sterile barrier Package testing performed on the proposed device (ISO 11138, IP)
- (vi)Seal strength EN 868-5
- Bubble test ASTM 2096 (vii)
- Dye Penetration ASTM F1929-15 (viii)
Shelf life: Shelf life of 5 years validated using FDA recognized ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
VIII. CONCLUSION
The difference between the predicate and subject device do not raise any new different questions of safety or effectiveness.
The SPM manufactured Insulin syringe is substantially equivalent to Insulin Syringe in K223453.
IX. Summary of Similarities & Difference of subject device with the predicate device and Justification:
The subject device shares equivalent indications for use, device operation, and overall technical and
9
functional capabilities to the predicate device. The difference in some materials of components, configuration, and sizes have been evaluated through non-clinical testing; the tests are in accordance with those established in the standards, ISO 7864-2016, ISO 9626:2016 & ISO 8537:2016. Therefore, the differences between the predicate device (K223453) and the subject device do not raise any new or different questions of safety or effectiveness. Performance testing data demonstrates that the proposed device is substantially equivalent to the predicate device with respect to the indications for use, target populations, and technological characteristics.