(141 days)
Not Found
Not Found
No
The summary describes a physical guidewire and does not mention any software, algorithms, or AI/ML related terms.
No
Explanation: A therapeutic device is designed to treat a medical condition or disease. This device is described as a guidewire to provide access, which is a diagnostic or procedural aid, not a treatment itself.
No
Explanation: The device is a guidewire designed to provide access to the tracheobronchial tree, which is an interventional function, not a diagnostic one. Its intended use and description do not mention diagnosing conditions.
No
The device description explicitly states it is constructed of a core wire, outer jacket, and a tip, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access to the tracheobronchial tree." This describes a physical intervention or tool used within the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details the physical construction of a guidewire, which is a medical device used for navigation and access during procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This Pulmonary Guidewire does not fit that description.
N/A
Intended Use / Indications for Use
The Pulmonary Guidewire is indicated for use to provide access to the tracheobronchial tree.
Product codes
79MDM
Device Description
The Pulmonary Guidewire is constructed of a core wire, outer jacket and a tip. The guidewire is designed to provide access to the tracheobronchial tree.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronchial tree
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
A biocompatibility assessment was performed on the patient- and fluid-contact materials of the device with satisfactory results.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
NOV 1 3 2002
p. 1/z
SECTION 11 510(k) SUMMARY
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| Date: | June 21, 2002 | |
|---|---|---|
| Common/Usual Names: | Instrument, Manual, General Surgical | |
| Trade/Proprietary Name: | The tradename of the device has not been finalized | |
| Classification Name & | ||
| Device Classification: | Class I | |
| Name | Product Code | 21 CFR Ref. |
| Instrument, Manual, General Surgical | 79MDM | 878.4800 |
| Device Panel/Branch: | General and Plastic Surgery (DGRND) | |
| Owner/Operator: | Boston Scientific Corporation | |
| One Boston Scientific Place | ||
| Natick, MA 01760 | ||
| Contact Person: | James D. McMahon | |
| Regulatory Affairs Specialist | ||
| Boston Scientific Corporation | ||
| One Boston Scientific Place | ||
| Natick, MA 01760-1537 |
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DESCRIPTION OF DEVICE
The Pulmonary Guidewire is constructed of a core wire, outer jacket and a tip. The guidewire is designed to provide access to the tracheobronchial tree.
INDICATIONS FOR USE
The Pulmonary Guidewire is indicated for use to provide access to the tracheobronchial tree.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
The major components of the predicate and proposed devices are identical. A thorough comparison of the descriptive characteristics between the proposed Pulmonary Guidewires and the predicate devices show equivalence.
PERFORMANCE CHARACTERISTICS
A biocompatibility assessment was performed on the patient- and fluid-contact materials of the device with satisfactory results.
CONCLUSION
Boston Scientific Corporation has demonstrated that the Pulmonary Guidewire is substantially equivalent to the Boston Scientific Corporation currently marketed Microvasive® Guidewires.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2007
Boston Scientific Corporation James D. McMahon Regulatory Affairs Specialist One Boston Scientific Place Natick, Massachusetts 01760-1537
Re: K022059
Trade/Device Name: Microvasive Pulmonary Guidewire Regulation Number: 878.4800 Regulation Name: Instrument, manual, general surgical Regulatory Class: Class I Product Code: MDM Dated: September 17, 2002 Received: September 20, 2002
Dear Mr. McMahon:
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 - Mr. James D. McMahon
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR Part 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,
Miriam C. Provost
10: Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE
510(k) Number:
Device Name:
Pulmonary Guidewire
Indication for Use:
The Pulmonary Guidewire is indicated for use to provide access to the tracheobronchial tree.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.1091) (Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Off) (Division of General, Restorative Division ological Devices
510(k) Number K022659