(15 days)
The intended use of the Simplicity QD Soft Infusion Set is to provide a means for infusion and/or The intended as of the body below the surface of the skin when attached to an external pump or syringe.
Sterling Medivations, Inc.'s ("SMI") Simplicity ™ QD Soft Infusion Set is designed for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe. The device consists of four main parts: (1) an infusion catheter made from Fluorinated Ethylene Propylene (FEP), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a female Luer connector. The Simplicity QD Soft Infusion Set is an infusion administration to a pump or syringe and inserted in the subculaneous tissue of a patient. The Sterling Medivations Simplicity QD Soft Infusion Set may infusion device that delivers continuous or intermittent flow. The administration set attaches to the pump or syringe by means of a female Luer connector, and subcutaneously in the patient through an indwelling catheter made of Fluorinated Ethylene Propylene (FEP). The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling FEP catheter is introduced into the subcutaneous tissue using an insertion needle. The insertion needle is removed and a connector housing is attached to the indwelling catheter. This connector needle part of the connector hub pierces a septum formits the infusion of medication without leakage. The connector needle is connecting tubing and a connector housing. The connector tubing proximal end is attached to a female Luer connector for attachment to the medicine reservoir. The connecting tube is solvent bonded to the connector housing and to the Luer connect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes.
The Sterling Medivations Simplicity QD Soft Infusion Set is a medical device for subcutaneous insulin infusion. The provided document is a 510(k) summary demonstrating its substantial equivalence to a predicate device, the Sterling Medivations Simplicity™ Silver Soft Infusion (K010846).
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Simplicity QD Soft Infusion Set are adherence to various ISO standards and FDA guidelines related to intravascular administration sets, sterilization, packaging, and Luer connectors. The document states that the device meets these requirements, implying performance in line with these standards. However, the document does not provide specific quantitative performance data (e.g., tensile strength values, leakage rates, or sterility assurance levels) or a direct comparison table. Instead, it offers a list of the standards the device is stated to comply with.
| Acceptance Criteria (Standard / Guideline) | Reported Device Performance |
|---|---|
| CDRH 21 C.F.R. section 880.54400 Intravascular administration set | Device meets these catheter requirements. |
| ISO 10555 Sterile, single-use intravascular catheters (Part 1: General Requirements) | Device meets these catheter requirements. |
| ISO 10555 Sterile, single-use intravascular catheters (Part 5: Peripheral catheters) | Device meets these catheter requirements. |
| ISO 9626 Stainless steel needle tubing for the manufacture of medical devices | Device meets these catheter requirements. |
| ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization (and repeated entry) | Device meets these catheter requirements. |
| ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization (and repeated entry) | Device meets these catheter requirements. |
| ISO 594-1: 1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements | Device meets these catheter requirements. |
| ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings | Device meets these catheter requirements. |
| ISO 11607: 1997 Packaging for terminally sterilized medical devices | Device meets these catheter requirements. |
| ISO 8537: 1991 Sterile single-use syringes, with or without needle for insulin | Device meets these catheter requirements. |
| FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test (ODE Blue Book Memorandum #K90-1) | Device meets these catheter requirements. |
| Center of Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (related to FDA 21 CGR 820.30 and Sub-clause 4.4 of ISO 9001) | The design process adhered to this guidance and is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set. It states that performance data supports substantial equivalence by meeting listed catheter requirements and ISO standards, but it doesn't describe specific tests, the number of devices tested, or the provenance of any data (e.g., country of origin, retrospective/prospective). This is typical for a 510(k) submission where equivalence is often demonstrated by adherence to recognized standards rather than new clinical trials or large-scale performance testing results detailed in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study presented is a technical assessment of compliance with standards, not a study involving expert review for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of expert review.
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
Not applicable. This is a 510(k) for a physical medical device (an infusion set), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established requirements and specifications within the referenced ISO standards and FDA regulations. The device's performance is compared against these predetermined technical and safety benchmarks, rather than against clinical outcomes, pathology, or expert consensus on clinical cases.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. This term is relevant for machine learning or AI models, which are not involved here.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned or implied.
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ਾ ਤੇ
Sterling Medivations, Inc. 25285 La Loma Drive Los Altos Hills, CA 94022 650-949-0470 (voice) 650-949-0342 (fax)
510(k) SUMMARY
| Date Submitted: | September 14, 2001 |
|---|---|
| Submitter: | Sterling Medivations, Inc. 25285 La Loma Drive, Los Altos Hills, CA 94022 Company Phone 650-949-0470, Company fax 650-949-0 |
| Contact: | Joel Douglas, Chief Technology Officer Sterling Medivations, Inc. Applicant Phone 650-949-0470, Applicant Fax 650-949-0342 |
| Trade Name of Device: | Simplicity™ QD Soft Infusion Set for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe. |
| Common Name of Device: | Intravascular administration set. |
| Classification Name: | Percutaneous intravascular catheter. |
Predicate Device: The predicate device for Sterling's Simplicity™ QD Soft Infusionset is the Sterling Medivations Simplicity™ Silver Soft Infusion, K010846.
Description of the New Device: Sterling Medivations, Inc.'s ("SMI") Simplicity ™ QD Soft Infusion Set is designed for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe.
The Simplicity ™ QD Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Sterling Medivations Simplicity Silver Soft Infusion, K010846 and it has the same intended use.
The device consists of four main parts: (1) an infusion catheter made from Fluorinated Ethylene Propylene (FEP), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a female Luer connector.
The Simplicity QD Soft Infusion Set is an infusion administration to a pump or syringe and inserted in the subculaneous tissue of a patient. The Sterling Medivations Simplicity QD Soft Infusion Set may infusion device that delivers continuous or intermittent flow.
The administration set attaches to the pump or syringe by means of a female Luer connector, and subcutaneously in the patient through an indwelling catheter made of Fluorinated Ethylene Propylene (FEP). The connecting tubing is made from a polyethylene tube.
The 25 gauge-indwelling FEP catheter is introduced into the subcutaneous tissue using an insertion needle. The insertion needle is removed and a connector housing is attached to the indwelling catheter. This connector needle part of the connector hub pierces a septum formits the infusion of medication without leakage. The connector needle is connecting tubing and a connector housing. The connector tubing proximal end is attached to a female Luer connector for attachment to the medicine reservoir. The connecting tube is solvent bonded to the connector housing and to the Luer connect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes.
Intended Use of the New Device: The intended use of the Simplicity QD Soft Infusion Set is to provide a means to infiuse or inject insulin subcutaneously when the device is attached to a pump or syringe
Comparisons of the Technological Features of the New Device and Predicate Device:
Page 1 of 2
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The Simplicity QD Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Sterling Medivations Simplicity Silver Soft Infusion 510(k) K010846.
The materials and manufacturing processes are substantially equivalent, the labeling is substantially equivalent to the Sterling Medivations Simplicity Silver Soft Infusion, FDA 510(k) K010846.
The differences that exist between the new and predicate device are as follows:
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The Simplicity QD Soft Infusion Set indwelling catheter is bonded to the hub with Loctite 322. The predicate device has an indwelling catheter which is press fit into the hub and sealed with Loctite 4011.
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The Simplicity QD Soft Infusion Set has a septum made of Silicone - ELASTOSIL ® R 401/40. The predicate device has a plug made of Silicone - ELASTOSIL ® R 401/40.
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The Simplicity QD Soft Infusion Set has a septum in the infusion hub for injecting with a syringe. The predicate device has a septum in the plug cover for injecting with a syringe.
Performance Data Supporting Substantial Equivalence: To provide substantial equivalence the Simplicity QD Soft Infusion Set meets the catheter requirements of:
CDRH 21 C.F.R. section 880.54400 Intravascular administration set,
ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements), and
ISO 10555 Sterile, single use intravascular catheters (Part 5: peripheral catheters).,
ISO 9626 Stainless steel needle tubing for the manufacture of medical devices,
ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization,
ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization.
ISO 594-1: 1986 Conical fittings with a 6% )Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements,
ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings,
ISO 11607: 1997 Packaging for terminally sterilized medical devices,
ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin,
ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization,
ISO 11138-2: 1994 Sterilization of health care products - Biological indicators - Part 2:Biological indicators for ethylene oxide sterilization.
FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. ODE Blue Book Memorandum #K90-1.
The design process adhered to is the Center of Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS. This Guidance relates to FDA 21 CGR 820.30 and Sub-clause 4.4 of ISO 9001. This is substantially equivalent to the predicate device.
Signed
I S. Douglas Chief Technology Officer
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2001
Mr. Joel Douglas Chief Technology Officer Sterling Medivations, Incorporated 25285 La Loma Drive Los Altos Hills, California 94022-4583
Re: K013104
Trade/Device Name: Simplicity QD Soft Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Adminstration Set Regulatory Class: II Product Code: FPA Dated: September 14, 2001 Received: September 17, 2001
Dear Mr. Douglas:
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 - Mr. Douglas
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 (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 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 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 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.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Simplicity QD Soft Infusion Set
Indications For Use:
The intended use of the Simplicity QD Soft Infusion Set is to provide a means for infusion and/or The intended as of the body below the surface of the skin when attached to an external pump or syringe.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(PER 21 CFR 801.109) /
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Patricia Cuscite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Page 7 of 103
§ 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.