K982853 · Davis & Geck, Inc. · GAP · Apr 30, 1999 · General, Plastic Surgery
Device Facts
Record ID
K982853
Device Name
SILK SUTURE
Applicant
Davis & Geck, Inc.
Product Code
GAP · General, Plastic Surgery
Decision Date
Apr 30, 1999
Decision
SN
Submission Type
Traditional
Regulation
21 CFR 878.5030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.
Device Story
Silk Non-Absorbable Surgical Suture consists of organic protein fibroin derived from Bombyx mori. Device used for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neural procedures. Features braided or twisted construction; available in white or dyed (black/blue); braided versions coated with silicone. Subject device utilizes automated needle end stiffening process applying medical-grade adhesive to silk strand, replacing manual nylon resin dipping process used in predicate. Suture is non-absorbable, though undergoes gradual in-vivo protein degradation. Used by surgeons in clinical settings to secure tissue; provides mechanical closure to facilitate healing.
Clinical Evidence
Bench testing only. Biocompatibility testing performed in accordance with ANSI/AAMI 10993 and USP guidelines, including cytotoxicity, hemolysis, sensitization, acute systemic toxicity, irritation, and intracutaneous testing.
Technological Characteristics
Material: Fibroin (organic protein from Bombyx mori). Construction: Braided or twisted; silicone coating on braided types. Manufacturing: Automated needle end stiffening using medical-grade adhesive. Form factor: Various lengths, diameters, with/without needles. Sterilization: Not specified.
Indications for Use
Indicated for general soft tissue approximation and/or ligation in patients requiring nonabsorbable sutures, including cardiovascular, ophthalmic, and neural procedures. Prescription use only.
Regulatory Classification
Identification
Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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4/30/99
# 510k Summary of Safety and Effectiveness
### SILK NON-ABSORBABLE SURGICAL SUTURE (w/UV-10 adhesive)
Submitted by: Sherwood-Davis & Geck 444 McDonnell Blvd. Hazelwood, MO 63042-2516
Contact: Vanada Johnson Sr. Regulatory Affairs Specialist
Date of Summary: May 7, 1998
Silk Non-Absorbable Surgical Sutures are composed of the organic protein fibroin which is derived from the domesticated species Bombyx mori (B.mori) of the family Bombycidae. Silk Surgical Sutures were initially cleared, via the Premarket Notification process and assigned 510(k) file number K930586. Silk Non-Absorbable Surgical Sutures are a class II device, per 21 CFR Section 878.5030, with the Classification Code 80GAP.
Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue. Silk sutures are braided or twisted and available in white or dyed (black or blue). Braided sutures (except for size 8/0) are coated with silicone. Silk sutures are also available in various lengths, diameters and quantities with or without surgical needles. SILK sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all the suture's tensile strength over time.
Similarities between the proposed Silk suture and the currently marketed Silk Non-Absorbable Surgical are 1) both are composed of the organic protein fibroin_ 2) both are sterile sutures, 3) both share the same indications for use, 4) both are available in the same various lengths, diameters, quantities, colors and sizes, 5) both are available with and without surgical needles and 6) both are packaged in identical Tyvek/Mylar packaging
The only difference between the proposed vs. the predicate Silk suture is an automated vs. a manual needle end stiffening process. The proposed Silk suture needle will be manufactured using an automated end stiffening process of applying the medical grade adhesive to a portion of the silk strand which is then cured and cut to length. The predicate Silk suture needle is currently manufactured using a manual end stiffening process of winding the suture material onto racks and dipping the end in a nylon resin bath, curing then cutting the suture to length.
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K982853
# Summary of Safety and Effectiveness SILK NON-ABSORBABLE SURGICAL SUTURE
Silk Non-Absorbable Surgical Sutures, with adhesive, were tested for biocompatibility in Silk Non-Austradic Burgroal Battleon, Wall actor of Medical Devices Part-1 : Evaluation
accordance to ANSI/AAMI 10993. Biological Evaluation of Medical Devices Parts USD accordance to ARGBARNI 10995. Destery of tests were performed in accordance to USP guidelines - Cytotoxicity, Hemolysis, Sensitization, Acute Systemic Toxicity, Irritation, Intracutaneous.
Sherwood-Davis & Geck considers the proposed Silk Surgical Suture (w/adhesive) to be substantially equivalent in design, composition and intended use, to the currently marketed Silk Suture covered under K930590.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1999
Ms. Vanada Johnson Scnior Regulatory Affairs Specialist Sherwood-Davis & Geck 444 McDonnell Boulevard Hazelwood, Missouri 63042
Re: K982853 Trade Name: Silk Suture Regulatory Class: II Product Code: GAP Dated. December 29, 1998 Received: February 12, 1999
Dear Ms. Johnson:
We have reviewed your Scction 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the incentions for use stated in the enclosure to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Tuesday, October 26, 1993 (Vol. 58, No. 205, Pages 57557 and 57558). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- 1. The Silk Suture is indicated for use in gencral soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological fronedures.
- 2. This device may not be manufactured from any material other than multifilamentous fibers composed of fibroin, an organic protein that is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manifacture of the Silk Suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
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Page 2 – Ms. Vanada Johnson
The general controls provisions of the Act include requirements for annual registration, The general controls provisions of the Act merade reques and prohibition against
listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adultcration.
Existing major regulations affecting your device can be found in the Code of Federal Existing major regulations arrecting your areas. A substantially equivalent determination Regulations (CFR), Title 21, Paris 800 to 872. Presctices (GMP) for Medical Dovices:
assumes compliance with the Good Manufacturing Practices (GMP inspections assumes compliance with the CFR Part 820) and that, through periodic GMP inspections,
General GMP regulation (21 CFR Part 820) and that, through periodic GMP regulations Fa General GMP regulation (21 CFR Fall 820) and may motions. Failure to comply
The Food and Drug Administration (FDA) will verify such assumptions. Frances The Food and Drug Administration (I'DA) wint venty on. In addition, FDA may publish
with the GMP regulation may result in regulatory action. In addition, Flease note: this with the GMP regulation may result in regulatory and Register. Please note: this further announcements concerning your device in taffect any obligation you might
response to your premarket notification submission does and a Flectronic Product response to your premarket notheation stimmission devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your \$10(k)
to be This letter will allow you to begin maticemig your device of your device and thus, ne premarket notification. The FDA miding of substablial of 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 desire Specific advice for your agains devices), please contact the Office of and additionally 607.10 for in this attistions on the promotion and Compliance at (301) 594-4323. Auditional (1871) of Compliance at (30) 594-4595.
advertising of your device, please contact the Office of Compliance at advertising of your deview, production catiled, "Misbranding by reference to premarket Also, please hote the regulation entitions, Trinitial on your responsibilities under the hottication (21 CFTN 807.77). Other golfSmall 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
Enclosure
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K982853
Page 1 of 1
510(k) Number (if known)
Device Name: Sherwood-Davis & Geck Silk Nonabsorbable Surgical Suture
Indications for Use:
Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.
(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE! IF NEEDED)
Concurrenc of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use _
(Division Sign-off)
Division Sign-Off)
(Division Division of General Restorative D 510(k) Number
510(k) Number -
Sherwood-Davis & Geck Silk Nonabsorbable Surgical Suture
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
