(52 days)
Not Found
No
The description focuses on the chemical composition, physical design, and mechanical performance of a topical skin adhesive and its applicator. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
No.
The device is a topical skin adhesive intended to hold closed skin edges of wounds; it does not treat or cure a disease or condition.
No
The device, Exofin® Precision Pen, is described as a sterile liquid topical skin adhesive intended for topical application to hold closed easily approximated skin edges of wounds. Its function is to approximate skin edges, not to diagnose a condition.
No
The device description clearly details physical components such as an aluminum tube, polyethylene-based applicator tip, silicone bulb, and polypropylene pen body, indicating it is a hardware device that delivers a topical adhesive.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical application only to hold closed easily approximated skin edges of wounds from surgical incisions... and simple, thoroughly cleansed, trauma-induced lacerations." This describes a device used directly on the body for a physical purpose (closing wounds), not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a topical skin adhesive and its application mechanism. There is no mention of reagents, samples (like blood, urine, etc.), or any process related to analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
The device is a topical adhesive used for wound closure, which falls under the category of medical devices used for physical intervention on the body.
N/A
Intended Use / Indications for Use
Exofin® Precision Pen is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.
Product codes
MPN
Device Description
Exofin® Precision Pen is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. The adhesive is provided in a 1.0g size, single-use, aluminum, collapsible tube that is fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disc and soft elastomeric brush. The aluminum tube is housed within a silicone bulb that is connected to a polypropylene pen body and held by the end user during application. The adhesive, applicator tip, silicone bulb and pen body are packaged together in a (PETG) plastic blister pack and sealed with a labeled Tyvek® blister backer. A total of 12 units are packaged in a tray which is covered by a sleeve. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity assists in the unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. The silicone bulb and pen body of the Exofin® Precision Pen were designed to improve ergonomics during application. In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
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
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
The following tests were performed on Exofin® Precision Pen to demonstrate substantial equivalence:
- Mechanical Applicator Testing
In these studies, Exofin® Precision Pen met all performance criteria. Because the adhesive, aluminum tube and applicator tip remain unchanged, no additional performance test were done.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4010 Tissue adhesive.
(a)
Tissue adhesive for the topical approximation of skin —(1)Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.(2)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
Tissue adhesive for non-topical use —(1)Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle and a human figure. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text to the right of the square.
September 9, 2021
Chemence Medical, Inc. Charnelle Thomas Director of Regulatory Affairs 200 Technology Drive Alpharetta, Georgia 30115
Re: K212246
Trade/Device Name: Exofin Precision Pen Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: August 9, 2021 Received: August 10, 2021
Dear Charnelle Thomas:
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,
Lixin Liu, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K212246
Device Name Exofin® Precision Pen
Indications for Use (Describe)
Exofin® Precision Pen is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, traumainduced lacerations. Exofin® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.
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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Image /page/3/Picture/0 description: The image contains the word "CHEMENCE" in a bold, sans-serif font. To the left of the word is a blue hexagon-like shape. The shape is made up of three overlapping, rounded rectangles that create a three-dimensional effect. The overall design is clean and modern.
Special 510(k) for Exofin® Precision Pen (K212246)
510(k) Summary
This 510(k) summary is prepared in accordance with 21 CFR 807.92.
1. Submitter
| Submitted by: | Chemence Medical, Inc.
200 Technology Drive
Alpharetta, GA 30005-3926
Phone: 844-633-4583
Fax: 678-820-3320 |
|------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charnelle Thomas
Director of Regulatory Affairs
Chemence Medical, Inc.
Phone: 678-690-0760
Email: cthomas@chemence.com |
| Date of Summary: | September 8, 2021 |
-
- Device
| Device Proprietary Name: | Exofin® Precision Pen |
|---|---|
| Common or Usual Name: | Topical Skin Adhesive |
| Classification Name: | Tissue Adhesive (21 CFR 878.4010) |
| Regulatory Class: | Class II |
| Product Code: | MPN |
3. Predicate Device
Legally marketed devices to which equivalence is claimed:
| Device Name: | Exofin® High Viscosity Topical Skin Adhesive |
|---|---|
| 510(k) Clearance: | K200264 |
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Special 510(k) for Exofin® Precision Pen (K212246)
4. Device Description
Exofin® Precision Pen is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. The adhesive is provided in a 1.0g size, single-use, aluminum, collapsible tube that is fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disc and soft elastomeric brush. The aluminum tube is housed within a silicone bulb that is connected to a polypropylene pen body and held by the end user during application. The adhesive, applicator tip, silicone bulb and pen body are packaged together in a (PETG) plastic blister pack and sealed with a labeled Tyvek® blister backer. A total of 12 units are packaged in a tray which is covered by a sleeve. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity assists in the unintended placement of the adhesive during application due to migration of the liguid adhesive from the wound site. The silicone bulb and pen body of the Exofin® Precision Pen were designed to improve ergonomics during application. In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
5. Intended Use
Exofin® Precision Pen is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.
6. Comparison of Technological Characteristics with the Predicate Device
Most technological characteristics of Exofin® Precision Pen and the predicate device are the same. Both devices:
- are 2-octyl cyanoacrylate-based, rapid polymerizing, liquid adhesive formulations
- contain D&C violet #2 colorant to aid in visualization during application ●
- provide an applicator tip that comprises of a connector, porous disc and soft elastomeric . brush
- polymerizes within minutes of application ●
- maintain skin edge approximation and provide a bacterial barrier ●
- are sterilized by a two-stage process with a sterility assurance level of 10° ●
The difference between Exofin® Precision Pen and the predicate is the addition of a pen (silicone bulb and pen body) for improved ergonomics during application and a change to increase the blister size to accommodate the pen body. Additionally, there is an increase in the number of device units in each tray from 10 to 12. The adhesive formulation, aluminum tube and applicator tip remain unchanged from the predicate device, Exofin High Viscosity Topical Skin Adhesive (K200264). These differences do not raise different questions of safety and effectiveness.
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Image /page/5/Picture/0 description: The image contains the word "CHEMENCE" in a bold, sans-serif font. To the left of the word is a blue hexagon-like shape. The shape is made up of three curved lines that overlap each other. The overall image appears to be a logo.
Special 510(k) for Exofin® Precision Pen (K212246)
7. Performance Data
Testing was performed in accordance with the FDA Class II Special Controls Guidance Document:Tissue Adhesive for the Topical Approximation of Skin.
Performance Testing
The following tests were performed on Exofin® Precision Pen to demonstrate substantial equivalence:
- · Mechanical Applicator Testing
In these studies, Exofin® Precision Pen met all performance criteria. Because the adhesive, aluminum tube and applicator tip remain unchanged, no additional performance test were done.
Biocompatibility Testing
The pen of subject device does not come into direct contact with the patient or adhesive, therefore,biocompatibility is not required. Because the adhesive is unchanged, no additional biocompatibility tests were performed.
Sterilization and Shelf Life
Exofin® Precision Pen is sterilized in a two-step process by dry heat and ethylene oxide gas at a sterility assurance level (SAL) of 10°. The shelf life of the device has been determined through both real time and accelerated aging studies. The data from these studies support a 12-month shelf-life.
8. Conclusion
Exofin® Precision Pen was evaluated in accordance with the Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. Exofin® Pen is substantially equivalent to Exofin® High Viscosity Topical Skin Adhesive with regard to indications for use, mechanism of action and performance characteristics. Both devices contain the same principle chemical ingredient, 2-octyl cyanoacrylate. Both devices were shown to be equivalent in performance testing. Therefore, the change of adding a silicone bulb and pen body, for improved ergonomics during application and a change to packaging dimensions to accommodate the pen size, do not raise different questions of safety and effectiveness.