(281 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data-driven algorithms.
No
The device is described as an "intravascular administration set used to administer medication subcutaneously" and its intended use is for "subcutaneous infusion of medication." It facilitates the delivery of therapeutic substances but does not, in itself, provide therapy or treatment.
No
Explanation: The device description and intended use clearly state that this is an infusion set for administering medication, not for diagnosing conditions.
No
The device description clearly outlines physical components such as a stainless-steel needle, wing stabilizer, luer connector, and medical dressing, 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 for the "subcutaneous infusion of medication administered by an external infusion pump or syringe." This describes a device used in vivo (within the body) for delivering substances.
- Device Description: The description details a set with a needle, tubing, and connectors for administering medication subcutaneously. This aligns with an in vivo administration device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing blood, urine, tissue, or other samples.
Therefore, the Safety Subcutaneous Infusion Set is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Safety Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external infusion pump or syringe.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Safety Subcutaneous Infusion Set is an intravascular administration set used to administer medication subcutaneously. The device consists of subcutaneous stainless-steel needle mounted to a wing stabilizer at 90° at the distal end of the infusion set. The subject device has closing type wings to allow the user to insert the needle into the subcutaneous tissue and also secure the needles on the infusion site. A female luer connector is provided at the proximal end to allow connection to external devices.
Each set consists of the administration set and standard medical dressing to secure the needles on the infusion site. The subject device is provided in various needle gauges and lengths. Each needle is equipped with an open end slide clamp on the tubing to facilitate stop flow when required during priming of individual needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
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)
The following non-clinical data were provided in support of the substantial equivalence determination:
- biocompatibility studies per ISO 10993-1:2018
- particulate matter per USP
- sterilization validation
- ethylene oxide residuals per ISO 10993-7:2008
- shelf life per ASTM F1980-16
- sharps protection per ISO 23908:2011
- tensile strength and water tightness per ISO 8536-8:2015
- luer lock connection test per ISO 80369-7
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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March 24, 2021
Epic Medical Pte. Ltd. % Roshana Ahmed Sr. Consultant, Regulatory Affairs Medical Devices Quaras, LLC 25 Independence Blvd. Warren, New Jersey 07059
Re: K201626
Trade/Device Name: Safety Subcutaneous Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: February 17, 2021 Received: February 19, 2021
Dear Roshana Ahmed:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201626
Device Name Safety Subcutaneous Infusion Set
Indications for Use (Describe)
The Safety Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external infusion pump or syringe.
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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K201626 510(k) Summary
I. Submitter
Epic Medical Pte. Ltd. 105 Cecil Street #20-04 The Octagon, Singapore 069534. Phone: +65 9635 2618 / +66 81 761 5292
Contact Person: Mr. Freddie Lee, Chief Executive Officer Date Prepared: February 16, 2021
II. Device
| Device Proprietary Name: | Safety Subcutaneous Infusion Set |
|---|---|
| Common or Usual Name: | Subcutaneous Administration Set |
| Classification Name: | Intravascular Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Product Code: | FPA |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- SUB-Q Subcutaneous Tissue Infusion Set, K140131, EMED Technologies Corporation ●
Device Description IV.
The Safety Subcutaneous Infusion Set is an intravascular administration set used to administer medication subcutaneously. The device consists of subcutaneous stainless-steel needle mounted to a wing stabilizer at 90° at the distal end of the infusion set. The subject device has closing type wings to allow the user to insert the needle into the subcutaneous tissue and also secure the needles on the infusion site. A female luer connector is provided at the proximal end to allow connection to external devices.
Each set consists of the administration set and standard medical dressing to secure the needles on the infusion site. The subject device is provided in various needle gauges and lengths. Each needle is equipped with an open end slide clamp on the tubing to facilitate stop flow when required during priming of individual needles.
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V. Indications for Use
The Safety Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external infusion pump or syringe.
VI. Comparison of Technological Characteristics
The Safety Subcutaneous Infusion Set has the same intended use as the predicate device (K140131). The Safety Subcutaneous Infusion Set has the same general design construction. proximal interface, number of lumens, range of needle gauge and length, tubing length, number of needles, needle safety feature, clamp type, wing type, and sterilization method/level as the predicate device (K140131).
The subject device differs from the predicate device with respect to needle protective cap design, materials of construction and packaging materials.
The table below compares the subject and predicate devices.
| Safety Subcutaneous Infusion | SUB-Q Subcutaneous Tissue | Comparison | |
|---|---|---|---|
| Set | Infusion Set | ||
| (K201626) | (K140131) | ||
| Indication for | |||
| Use | The Safety Subcutaneous Infusion | ||
| Set is indicated for subcutaneous | |||
| infusion of medication | |||
| administered by an external | |||
| infusion pump or syringe. | SUB-Q Subcutaneous Infusion | ||
| Set is intended to provide | |||
| subcutaneous infusion of | |||
| medicine from an external | |||
| infusion pump or syringe. | Same as predicate | ||
| Proximal | |||
| interface | Female Luer Lock | Female Luer Lock | Same as predicate |
| Tubing length | 40 cm | 5 cm ~ 91.4 cm | Similar to predicate |
| Needle gauge | 24, 26, and 27 | 24 and 27 | Similar to predicate |
| Needle lengths | 6mm, 9mm, 12mm | 6mm, 9mm, 12mm, 14mm and | |
| 16mm | Same as predicate | ||
| Number of | |||
| needles | 1 - 4 | 1 - 4 (up to 8 with Y connector) | Same as predicate |
| Needle lubricant | Polydimethylsiloxane (PDMS) | Polydimethylsiloxane (PDMS) | Same as predicate |
| Wing type | Closed, Needle protecting | Standard and Closed | Same as predicate |
| Needle | |||
| protective cap | Sliding | Tubular sheath | Different |
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| | Safety Subcutaneous Infusion
Set
(K201626) | SUB-Q Subcutaneous Tissue
Infusion Set
(K140131) | Comparison |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Needle safety
feature | Needle inaccessible to user before
engaging.
Sharp protection feature
compliant to ISO 23908:2011. | Needle inaccessible to user before
engaging.
Sharp protection feature
compliant to ISO 23908:2011. | Same as predicate |
| Sterilization | ETO, SAL of 10-6 | ETO, SAL of 10-6 | Same as predicate |
| Priming volume | 24-gauge needle: 0.4 ~ 1.4
27-gauge needle: 0.1 ~ 0.4 | 24-gauge needle: 0.16 ~ 0.8
27-gauge needle: 0.12 ~ 0.8 | Similar to predicate |
| Transparent
dressing | Off-the-shelf dressing purchased
from:
3M Healthcare | Off-the-shelf dressing purchased
from:
3M Healthcare | Same as predicate |
| Component
materials | Luer lock: ABS
Luer cap: LDPE
Tubing: PVC
Wings: Polypropylene and
Thermoplastic elastomer
(locking)
Protective cap: Polycarbonate
Needles: Stainless steel
Slide clamp: Polyethylene
Bonding agent: Cyanoacrylate | Luer lock: PVC
Luer cap: Polypropylene
Tubing: PVC
Wings: PVC (std) and
Polypropylene (locking)
Protective cap: Polypropylene
Needles: Stainless steel
Slide clamp: ABS
Bonding agent: Cyanoacrylate | Different |
Discussion
The Safety Subcutaneous Infusion Set has the same intended use as the predicate device and both the subject and predicate device share the same design, proximal interface, needle lengths, number of needles and needle safety feature, and wing type. The subject device tubing length and needle gauges and fall within the range of tubing length and needle gauges for the predicate device.
The subject device differs from the predicate device with respect to protective cap design (sliding cap design vs. tubular sheath design), priming volume (slight difference in priming volume), and materials of construction for a subset of components. These technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness and are addressed by the performance and biological safety testing identified below.
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VII. Performance Data
The following non-clinical data were provided in support of the substantial equivalence determination:
- biocompatibility studies per ISO 10993-1:2018
- particulate matter per USP
- sterilization validation
- ethylene oxide residuals per ISO 10993-7:2008 ●
- shelf life per ASTM F1980-16
- sharps protection per ISO 23908:2011
- . tensile strength and water tightness per ISO 8536-8:2015
- luer lock connection test per ISO 80369-7
VIII. Conclusion
The information provided above supports that the Safety Subcutaneous Infusion Set is as safe and effective as the predicate device. Although there are minor technological differences between the subject and predicate devices, these difference do not raise different questions of safety and effectiveness. Therefore, it is concluded that the Safety Subcutaneous Infusion Set is substantially equivalent to the predicate device.