(45 days)
Not Found
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is used for "BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION," which are all procedures aimed at treating or correcting medical conditions or defects.
No
Explanation: The intended use of this device explicitly states "BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION," which are all therapeutic or corrective procedures, not diagnostic ones.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Breast Reconstruction, Limb Reconstruction, Correction of Congenital Deformities, Cosmetic Defects, Scar Revision) are all related to surgical procedures and physical reconstruction. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- No mention of biological specimens: There is no indication that this device interacts with or analyzes biological samples.
- No mention of diagnostic purposes: The intended uses are therapeutic and reconstructive, not diagnostic.
Therefore, based on the provided text, this device falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION
Product codes (comma separated list FDA assigned to the subject device)
FZW, LCJ
Device Description
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Mentions image processing
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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 (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.
Not Found
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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10/13/2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a blue square and the name in a sans-serif font.
Wells Johnson Company Ken Rodenburg Technical Manager Post Office Box 18230 Tucson, Arizona 85731-8230
Re: K98448
Trade/Device Name: Bircoll Balloon Dissector Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: FZW
Dear Ken Rodenburg:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 28, 1999. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code FZW.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Deborah Fellhauer, OHT4: Office of Surgical and Infection Control Devices, 301-796-9570, Deborah.Fellhauer@fda.hhs.gov.
Sincerely,
Deborah A. Fellhauer -S Deborah A. Fellhauer -S 2022.10.13 13:17:10 -04'00'
Deborah A. Fellhauer RN, BSN 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
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wing. The text "OF HEALTH & HUMAN SERVICES - USA" is arranged in an arc above the eagle. The acronym "DHHS" is placed below the eagle, rotated 180 degrees.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Mr. Ken Rodenburg Wells Johnson Company Post Office Box 18230 Tucson, Arizona 85731-8230
Re: K984448 Trade Name: Bircoll Balloon Dissector Regulatory Class: Unclassified Product Code: LCJ Dated: December 8, 1998 Received: December 14, 1998
Dear Mr. Rodenburg:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that May 20, 1978, sisted in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costiners 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 – Mr. Ken Rodenburg
This letter will allow you to begin marketing your device as described in your 510(k) Fridation will and n yourse bogan finding of substantial equivalence of your device to a promative notified 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 If you dosire specific as a for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and Compliance at (301) 594 please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Allot, prease flow the regal. 97). Other general information on your responsibilities under the nothroution (21 Cricon the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
- Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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များပပ
Page
K984448 510(k) NUMBER (IF KNOWN):
Bircoll Balloon Dissector DEVICE NAME:
INDICATIONS FOR USE:
BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | 2984448 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
510(k) Number
Division of General Restorative Devices
(Division Sign-Off)
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