LUTH-ALL SUB-Q NEEDLE SET

K042666 · Luth-All Medical Products, LLC · FPA · Dec 21, 2004 · General Hospital

Device Facts

• Record ID: K042666
• Device Name: LUTH-ALL SUB-Q NEEDLE SET
• Applicant: Luth-All Medical Products, LLC
• Product Code: FPA · General Hospital
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Luth-All Safety Sub-Q Needle Set is a device intended to administer drugs to a patient from a container by infusion subcutaneously. It operates as a standard safety needle with the addition of a built in active safety feature which when activated the device is designed to aid in reducing the possibility of accidental needle sticks. The device intended to be used only by trained personnel to administer drugs to a patient from a container by infusion subcutaneously. Typical use would be for example to administer Insulin. The needle is placed subcutaneously during therapy. After the needle placement, the device is connected to a syringe or other delivery devices, via a standard luer connection, to administer the drugs. When the infusion is completed, the device is removed by activating the safety feature, and discarded according to the appropriate disposal procedure for the health provider.

Device Story

Luth-All Safety Sub-Q Needle Set is a sterile, single-use needle and administration set for subcutaneous drug delivery; features integrated active safety mechanism to prevent accidental needlesticks. Device connects to syringes or infusion pumps via standard luer connection; placed subcutaneously by trained personnel. Following infusion, safety feature is manually activated prior to disposal. Device aids in reducing needlestick injuries for healthcare providers; facilitates controlled drug administration for patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Needle and administration set; medical-grade biocompatible materials; standard luer connection; integrated active safety mechanism for needle shielding; sterile, single-use.

Indications for Use

Indicated for subcutaneous drug administration (e.g., insulin) in patients requiring infusion therapy. Intended for use by trained healthcare personnel only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Luther Safety Huber Needle Set (K021565)
• Evans Sub-Q (Catalog # 4206) (K020530)

Submission Summary (Full Text)

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DEC 2 1 2004

K042666

510(k) Luth-All Safety Sub-Q Needle Set

## 510(k) SUMMARY

| Submitted by: | Luth-All Medical Products, LLC<br>3199 Airport Loop Drive, Unit E<br>Costa Mesa, CA 92656<br>[phone] Phone [phone] FAX |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shepard G. Bentley<br>Synergy Biomedical, LLC<br>28202 Cabot Road, Suite 300<br>Laguna Niguel, CA 92677<br>[phone] Phone [phone] FAX<br>E:Mail [e-mail] |
| Date Prepared: | 27 September 2004 |
| Device Name: | Luth-All Safety Sub-Q Needle Set |
| Trade Name: | Luth-All Safety Sub-Q Needle Set |
| CommonName: | Safety Needle and Administration Set |
| Classification Name: | Set, Administration, Intravascular |
| Device Class: | II (two) |
| Procode: | FPA |
| CFR Reference: | 880.5440 |
| Predicate Device #1: | Luther Safety Huber Needle Set |
| Predicate 510(k) #1: | K021565 |
| Predicate Device #2: | "Evans Sub-Q" (Catalog # 4206) |
| Predicate 510(k) #2: | K020530 |
| Device Description: | The Luth-All Safety Sub-Q Needle Set is a needle and<br>administration set with a needlestick prevention feature,<br>designed for use with a vascular access infusion system. It is<br>manufactured with conventional medical grade, biocompatible<br>materials. It operates as a standard safety needle with the<br>addition of a built in active safety feature, which when<br>activated the device is designed to aid in reducing the<br>possibility of accidental needle sticks.<br>It is supplied sterile for single use only. |
| Indications for Use: | The Luth-All Safety Sub-Q Needle Set is a device intended to<br>administer drugs to a patient from a container by infusion<br>subcutaneously. It operates as a standard safety needle with<br>the addition of a built in active safety feature which when |

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activated the device is designed to aid in reducing the possibility of accidental needle sticks.

- The device intended to be used only by trained personnel to Intended Use: administer drugs to a patient from a container by infusion subcutaneously. Typical use would be for example to administer Insulin. The needle is placed subcutaneously during therapy. After the needle placement, the device is connected to a syringe or other delivery devices, via a standard luer connection, to administer the drugs. When the infusion is completed, the device is removed by activating the safety feature, and discarded according to the appropriate disposal procedure for the health provider.
- Technological Comparison: A summary of the technological characteristics of this device compared to the predicate device can be seen in the Comparison Table in the Specifications Section. This device and the predicate have similar technological characteristics and are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around a symbol. The symbol consists of three stylized lines that resemble a bird in flight or a wave pattern. The seal is black and white and appears to be a logo or emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2004

Luth-All Medical Products, LLC C/O Mr. Shepard G. Bentley Regulatory Consultant Synergy Biomedical, LLC 28202 Cabot Road, Suite 300 Laguna Niguel, California 92677

Re: K042666

Trade/Device Name: Luth-All Safety Sub-Q Needle Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 12, 2004 Received: November15, 2004

Dear Mr. Bentley:

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.

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Page 2 - Mr. Bentley

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 vour 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ch. L.

Chiu 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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## Indications for Use

510(k) Number (if known): ___K042666

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Luth-All Safety Sub-Q Needle Set is a device intended to administer drugs to a Fine Dail 7 in Barey by infusion subcutaneously. It is manufactured with patient from a container of miocompatible materials. It operates as a standard safety oon oncellar modition of a built in active safety feature, which when activated the device is designed to aid in reducing the possibility of accidental needle sticks.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthen v.n

Division Sicn-Off) ( . 17.301 Step Off)
Division of Anesthesioniogy, General Hospital, Infection Control, Denta, Devices

510(k) Number. K942666

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