(24 days)
NONE - Class I; 510(k) exempt, NONE - Class I; 510(k) exempt
Not Found
No
The summary describes a mechanical device for skin biopsy and wound closure, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is used to remove skin lesions and provide wound closure (mechanical action), which are diagnostic and procedural functions, not therapeutic.
No
The device is described as a tool for obtaining biopsy specimens and removing skin lesions, and providing wound closure. Its intended use focuses on physical intervention (biopsy, removal, closure) rather than diagnosing a condition. Obtaining a biopsy specimen is a step in the diagnostic process, but the device itself does not perform the diagnosis.
No
The device description clearly states it is a physical, single-use, disposable device consisting of a skin clip, blade, and manual delivery system. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing happens outside the body (in vitro).
- ExiClip™ EXCS-M Function: The ExiClip™ EXCS-M is a surgical device used to obtain a biopsy specimen and remove skin lesions. It also provides wound closure. Its primary function is a physical intervention on the body, not the analysis of a specimen after it's been removed.
- Lack of Diagnostic Testing: The description focuses on the physical act of biopsy and wound closure. There is no mention of any testing or analysis performed on the collected specimen by the device itself.
The device is a tool for obtaining a sample and managing the wound, not for performing a diagnostic test on that sample.
N/A
Intended Use / Indications for Use
The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.
Product codes (comma separated list FDA assigned to the subject device)
MJG, GDO, FZQ
Device Description
The ExiClip™ EXCS-M skin biopsy with wound closure device is a single use, disposable device consisting of a removable skin clip, a blade, and a manual delivery system. The device is to be provided sterile. The skin clip is non-absorbable. The skin clip provides wound closure and must be removed after the wound has healed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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)
Not Found
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.
NONE - Class I; 510(k) exempt, NONE - Class I; 510(k) exempt
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
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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APP 9 6 3 311
510(k) CleveX Inc. ExiClip™ EXCS-M Page 32 of 33
- 510(k) Summary
Summary of Safety and Effectiveness for the ExiClip™ EXCS-M
Date Prepared
March 21, 2007
Sponsor
CleveX Inc. 1275 Kinnear Rd Columbus, OH 43212 (614) 675-3757 Telephone: Facsimile: (614) 675-3758 Email: smithg@clevex.com
Official Contact Person
Lena Sattler Orasi Consulting, LLC. 9996 Carrousel Ct. Loveland, OH 45140 Telephone: (440) 554-3706 (866) 904-4315 Facsimile: LenaSattler3@aol.com E-mail:
Common/Usual Name
Device, Percutaneous Biopsy; Clip Applier; Removable Skin Clip
Proprietary Names
ExiClip™ EXCS-M
Classification Information
| Classification Name(s): | Device, Percutaneous Biopsy
Applier, Surgical Clip
Removable Skin Clip |
|-------------------------|------------------------------------------------------------------------------------------------|
| Medical Specialty: | General & Plastic Surgery |
| Device Class: | I (each of three) |
| Classification Panel: | General & Plastic Surgery Device Panel |
| Product Codes: | MJG – Device, Percutaneous Biopsy
GDO – Applier, Surgical Clip
FZQ - Removable Skin Clip |
CleveX Inc. Proprietary and Confidential Information 1275 Kinnear Rd, Columbus, OH 43212 March 21, 2007
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510(k) CleveX Inc. ExiClip™ EXCS-M Page 33 of 33
Identification of a Legally Marketed Predicate Device
| Trade/Device Name: | Shoney Scientific Disposable Punch
Biopsy |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) Premarket Notification number:
FDA Product Code: | NONE - Class I; 510(k) exempt
MJG - Device, Percutaneous Biopsy |
| Trade/Device Name: | AutoClip® Applier; AutoClip® Wound
Clip (Device: Skin Clip w/ Applicator |
| 510(k) Premarket Notification number:
FDA Product Code: | NONE - Class I; 510(k) exempt
GDO - Applier, Surgical Clip
FZQ - Removable Skin Clip |
General Description
The ExiClip™ EXCS-M skin biopsy with wound closure device is a single use, disposable device consisting of a removable skin clip, a blade, and a manual delivery system. The device is to be provided sterile. The skin clip is non-absorbable. The skin clip provides wound closure and must be removed after the wound has healed.
Indications for Use
The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.
Summary of Technological Characteristics
The ExiClip™ EXCS-M device is substantially equivalent to the Shoney Scientific punch biopsy in that both devices provide a tissue sample suitable for pathology analysis or remove skin lesions. Both devices are manually powered. Both devices utilize stainless steel blades. Both devices are provided sterile. Both devices have the same intended use - removal of skin lesions and/or provide a tissue sample for pathological analysis.
The ExiClip™ EXCS-M device is substantially equivalent to the AutoClip® Wound Clip with Applier Device (Skin Clip) in that both devices deploy a skin clip for wound closure by activation by plastic deformation of the stainless steel clips via the use of an applier. Both clip appliers have the same intended use which is to apply a surgical clip for wound closure.
The ExiClip™ EXCS-M skin clip has been found to have a comparable retention force to the AutoClip® Wound Clip. Both devices utilize a clip made of stainless steel. Both devices are manually powered. Both devices have the same intended use which is a non-absorbable skin clip for wound closure.
CleveX Inc. Proprietary and Confidential Information 1275 Kinnear Rd. Columbus. OH 43212 March 21, 2007
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle with three stylized lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cleve X, Incorporated % Orasi Consulting, LLC Ms. Lena Sattler 9996 Carrousel Court Loveland, Ohio 45140
APR 2 0 2007
Re: K070836 Trade/Device Name: ExiClip™ EXCS-M Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: MJG, GDO, FZO Dated: March 22, 2007 Received: March 27, 2007
Dear Ms. Sattler:
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. 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.
3
Page 2 -- Ms. Lena Sattler
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 your 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 7. Indications for Use Statement | |
|---|---|
| 510(k) Number (if known): | K070836 |
| Device Name: | ExiClip™ EXCS-M |
Indications for Use:
The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) | 510(k) Number |
| K070836 | |
|---|---|
| Over-The-Counter Use | |
| (Per 21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
CleveX Inc. Proprietary and Confidential Information 1275 Kinnear Rd, Columbus, OH 43212 March 21, 2007